Total 127 quality assurance manager job vacancies in Quality Assurance / Control category in Singapore

About Us

Vivo Surgical is a patient-focused, clinician-driven medical device developer and manufacturer. Headquartered in Singapore with offices in China and Thailand, we are pioneering a novel endoscopic surgical robot for complex endoluminal surgeries. ISO 13485 certified with international accreditations awarded such as the US FDA and European CE mark, our devices target the medical needs of the world through innovative applications of science & technology. These encompass such fields as in vivo surgical LED lighting, portable endoscopy and endoscopic robots, which are strategically co-developed with world-class healthcare institutions and KOL collaborators. Join us as we build towards our vision of being Asia Pacific’s leading medical device developer and manufacturer.

About The Role

We value the importance of having a robust Quality Assurance and Regulatory Affairs team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Quality Assurance & Regulatory Affairs Manager to join us on this journey. You will be part of our fast-growing team and will take ownership of your role from the get-go. You will work on ensuring our company’s commitment to comply with regulatory requirements and to maintain the effectiveness of our Quality Management System (QMS). You will also be in charge of our products’ regulatory strategies and submissions to various regulatory bodies. Your role will enable you to work not only with diverse functions internally but also in close tandem with our external partners such as our suppliers, distributors and notified bodies.

Your responsibilities shall include the following:

• Ensure the company’s QMS complies with ISO 13485 and FDA 21 CFR 820/QMSR.
• Develop and manage Quality Procedures such as document control, CAPA, NCR, Supplier Control, Production Control, Feedback and Complaints Handling, and Post Market Surveillance.
• Organize and execute internal audits, management reviews and supplier audits.
• Plan and lead ISO 13485 audits and regulatory inspections.
• Participate in the products’ verification and validation activities.
• Develop, review and compile the medical device technical files whilst making sure the products meet all regulatory and quality standards.
• Involved in risk assessment tasks to identify potential quality and compliance risks in the product lifecycle and advise adequate risk control measures.
• Serve as the company’s Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC).
• Manage and mentor the QARA team to ensure members are adequately trained.
• Stay updated on medical device laws and regulations in the targeted markets.
• Work with senior management to define and deliver adequate quality and regulatory strategies.

Your Qualifications & Experience

• Minimum Bachelor’s degree in Engineering or Science.
• At least 5 years’ experience in quality assurance and/or regulatory affairs in the medical device Industry.
• Firm understanding of ISO 13485:2016, FDA 21 CFR 820/QMSR and ISO 14971.
• Prior involvement in HSA, FDA 510(k)/De Novo and/or MDR 2017/745 submissions will be a plus.
• Experience in generating risk management documentation (risk management plan, report, FMEAs).
• Possess a leadership and strategic mindset to organize and prioritize tasks for effective and timely delivery of regulatory goals to meet the company’s business objectives.
• Certification as an ISO13485:2016 lead auditor will be advantageous.

Contact

Please send your CV and cover letter to: [email protected]. We look forward to receiving your application.

Job Description & Requirements

Review the inspection history to summarize the integrity status of the plant equipment and piping systems.

· Perform the scoping work and prepare the job pack for process piping and in-service equipment based on engineering assessment and annual inspection plan.

· Plan and carry out fixed equipment/piping inspection via on-stream risk-based monitoring programs and downtime inspection activities including corrosion under Insulation (CUI) and corrosion under pipe support (CUP) on process piping and equipment according to annual maintenance plan

· Identifying the areas of special concern and deterioration (e.g. Dead legs, injection points, mix points, corrosion under insulation and Low silicon Inspection).

· Supervision and coordination of all on-stream and shutdown inspection and NDT activities for static equipment and in-service process piping.

· Review of inspection test plan, WPS and method statement for any in-service repair work of piping and pressure vessels.

· Witnessing of PT, MPI, PMI, metallographic tube testing and Hydro static test for statutory equipment.

· Provide recommendations and timely updates on equipment degradation problems.

· Provide quality assurance on project construction and maintenance works to ensure compliance with applicable codes, standards and specifications.

· Preparation of final inspection reports with all findings, abnormalities and recommendations.

· Ensure quality of inspected items to meet project requirements and standards.

· Inservice inspections in refineries / Oil and Gas / Petrochemical industries, such as corrosion under pipe support (CUPS), corrosion under insulation (CUI), Injection & Mix points inspections.

· Read, understand project related ITP, procedures, specification requirements.

· Review documents and drawings as per specification • Knowledge / experience about Piping Isometrics, P & ID, general arrangement drawings, Structural drawings, Weld Maps, welding symbols, Cutting Plans, Quality control procedures, Base Materials, and welding consumables.

· Inspection, review of mill certificates, Material verification, Inspection of Pipes, Fittings, Flanges, valves, nipples, plate tubes as per respective materials specifications, Codes, Standards & Client Specifications. Inspection / Witness & Review Stage wise activities earlier stage of spool fabrication

· Knowledge in welding inspection

Eligibility Criteria

· Graduate Engineers with 3-6 years of relevant experience.

· Relevant Engineering Degree or Diploma in Mechanical, Petroleum/Oil/Gas, Civil, Chemical or Industrial Engineering are acceptable.

· Experience in Refinery and Oil & Gas must

· Experience in QA/QC and Knowledge in Non-Destructive Testing methods.

· Knowledge/experience in welding inspection, structural fabrication, piping Isometric drawing and piping materials.

· Work Independently and can work in Singapore and other countries.

· Fluent Reading, Speaking and Writing in English.

· Willing to commit 24 months contract/ project completion.

· Team Worker, Mature, Meticulous, Pro-Active Work Attitude & Work Independent.

· Energetic & Result Orientated.

Job Description & Requirements

Review the inspection history to summarize the integrity status of the plant equipment and piping systems.

· Perform the scoping work and prepare the job pack for process piping and in-service equipment based on engineering assessment and annual inspection plan.

· Plan and carry out fixed equipment/piping inspection via on-stream risk-based monitoring programs and downtime inspection activities including corrosion under Insulation (CUI) and corrosion under pipe support (CUP) on process piping and equipment according to annual maintenance plan

· Identifying the areas of special concern and deterioration (e.g. Dead legs, injection points, mix points, corrosion under insulation and Low silicon Inspection).

· Supervision and coordination of all on-stream and shutdown inspection and NDT activities for static equipment and in-service process piping.

· Review of inspection test plan, WPS and method statement for any in-service repair work of piping and pressure vessels.

· Witnessing of PT, MPI, PMI, metallographic tube testing and Hydro static test for statutory equipment.

· Provide recommendations and timely updates on equipment degradation problems.

· Provide quality assurance on project construction and maintenance works to ensure compliance with applicable codes, standards and specifications.

· Preparation of final inspection reports with all findings, abnormalities and recommendations.

· Ensure quality of inspected items to meet project requirements and standards.

· Inservice inspections in refineries / Oil and Gas / Petrochemical industries, such as corrosion under pipe support (CUPS), corrosion under insulation (CUI), Injection & Mix points inspections.

· Read, understand project related ITP, procedures, specification requirements.

· Review documents and drawings as per specification • Knowledge / experience about Piping Isometrics, P & ID, general arrangement drawings, Structural drawings, Weld Maps, welding symbols, Cutting Plans, Quality control procedures, Base Materials, and welding consumables.

· Inspection, review of mill certificates, Material verification, Inspection of Pipes, Fittings, Flanges, valves, nipples, plate tubes as per respective materials specifications, Codes, Standards & Client Specifications. Inspection / Witness & Review Stage wise activities earlier stage of spool fabrication

· Knowledge in welding inspection

Eligibility Criteria

· Graduate Engineers with 3-6 years of relevant experience.

· Relevant Engineering Degree or Diploma in Mechanical, Petroleum/Oil/Gas, Civil, Chemical or Industrial Engineering are acceptable.

· Experience in Refinery and Oil & Gas must

· Experience in QA/QC and Knowledge in Non-Destructive Testing methods.

· Knowledge/experience in welding inspection, structural fabrication, piping Isometric drawing and piping materials.

· Work Independently and can work in Singapore and other countries.

· Fluent Reading, Speaking and Writing in English.

· Willing to commit 24 months contract/ project completion.

· Team Worker, Mature, Meticulous, Pro-Active Work Attitude & Work Independent.

· Energetic & Result Orientated.

Job Description & Requirements

Review the inspection history to summarize the integrity status of the plant equipment and piping systems.

· Perform the scoping work and prepare the job pack for process piping and in-service equipment based on engineering assessment and annual inspection plan.

· Plan and carry out fixed equipment/piping inspection via on-stream risk-based monitoring programs and downtime inspection activities including corrosion under Insulation (CUI) and corrosion under pipe support (CUP) on process piping and equipment according to annual maintenance plan

· Identifying the areas of special concern and deterioration (e.g. Dead legs, injection points, mix points, corrosion under insulation and Low silicon Inspection).

· Supervision and coordination of all on-stream and shutdown inspection and NDT activities for static equipment and in-service process piping.

· Review of inspection test plan, WPS and method statement for any in-service repair work of piping and pressure vessels.

· Witnessing of PT, MPI, PMI, metallographic tube testing and Hydro static test for statutory equipment.

· Provide recommendations and timely updates on equipment degradation problems.

· Provide quality assurance on project construction and maintenance works to ensure compliance with applicable codes, standards and specifications.

· Preparation of final inspection reports with all findings, abnormalities and recommendations.

· Ensure quality of inspected items to meet project requirements and standards.

· Inservice inspections in refineries / Oil and Gas / Petrochemical industries, such as corrosion under pipe support (CUPS), corrosion under insulation (CUI), Injection & Mix points inspections.

· Read, understand project related ITP, procedures, specification requirements.

· Review documents and drawings as per specification • Knowledge / experience about Piping Isometrics, P & ID, general arrangement drawings, Structural drawings, Weld Maps, welding symbols, Cutting Plans, Quality control procedures, Base Materials, and welding consumables.

· Inspection, review of mill certificates, Material verification, Inspection of Pipes, Fittings, Flanges, valves, nipples, plate tubes as per respective materials specifications, Codes, Standards & Client Specifications. Inspection / Witness & Review Stage wise activities earlier stage of spool fabrication

· Knowledge in welding inspection

Eligibility Criteria

· Graduate Engineers with 3-6 years of relevant experience.

· Relevant Engineering Degree or Diploma in Mechanical, Petroleum/Oil/Gas, Civil, Chemical or Industrial Engineering are acceptable.

· Experience in Refinery and Oil & Gas must

· Experience in QA/QC and Knowledge in Non-Destructive Testing methods.

· Knowledge/experience in welding inspection, structural fabrication, piping Isometric drawing and piping materials.

· Work Independently and can work in Singapore and other countries.

· Fluent Reading, Speaking and Writing in English.

· Willing to commit 24 months contract/ project completion.

· Team Worker, Mature, Meticulous, Pro-Active Work Attitude & Work Independent.

· Energetic & Result Orientated.

Job Description

• Provides support on quality systems, processes, and procedures to ensure compliance with FM Contract, Company’s, and ISO policies.
• Responsible for preparing and conducting quality control checks, investigations for potential quality non-conformance, compliance concerns and recommend follow-up actions to mitigate such issues on Building Facilities including M&E Systems, Building Systems and soft services.
• Prepare report for management review and facilitate for follow-up actions required.
• Attend regular maintenance meetings on behalf of the Company with Clients and Clients’ Representatives.
• Lead the internal audit program for operation site include identifying opportunities for quality systems’ improvements and meet company’s quality objectives.
• Maintain good records and filing systems of reports for future reference and coordination

Job Requirement

• At least 3-5 years relevant working experience in Engineering, Facilities or Estates Management, Quality Management Systems, Quality Control or equivalent.
• Minimally Diploma in any Engineering field, Facilities or Estates Management or equivalent with knowledge in ISO Standards 9001, 14001 and/or 41001.
• Certified QMS Auditor / Lead Auditor in ISO or equivalent will be advantageous.
• Pro-active, independent yet service and team-oriented, and able to perform under pressure with minimal supervision.
• Strong interpersonal and communication skills with ability to work cross-functionally with different departments to meet timeline and objectives.
• Location is at Singapore Polytechnic
• 5.5 work day

Responsibilities

• Internal and external excursion management (MRB / Quality Claims)
• Customer data reporting
• Conduct Quality related training
• Support customer survey and audits
• Continuous improvement activities

Requirements

• Bachelor's degree in Engineering or Science.
• Strong systematic and analytical problem-solving abilities.
• Proactive attitude with the ability to handle multiple tasks simultaneously.
• Excellent communication skills and a collaborative team player.
• Understanding of system flow and databases; basic SQL knowledge is advantageous.
  

For Experienced Candidates:

• Proven experience with QA tools such as 8D, FMEA, fishbone diagrams, and AND.
• Solid working knowledge of Statistical Process Control (SPC) and auditing practices.

For Entry-Level Candidates:

• Willingness to learn and adapt to new QA tools and methodologies.
• Basic understanding of quality assurance principles and practices.
• Freshgraduate with part time working experience during Uni time (aside from internship) is a plus.

Mon to Fri 8.30am - 5.30pm

Objectives of the position:

This role is for the validation of Customer technical requirements by means of inspection of In-coming goods and release lots in SAP with defined usage decisions. Testing of ISIR samples (type test) for product approval process (power, control & data cable) with compliance to company standards and verify compliance to the international cable standards e.g. EN / IEC requirements. Understanding of each testing standards and be able to communicate the requirements to respective parties including suppliers. Establish test specification to be followed by suppliers. To be able to operate all laboratory equipment in the process of cable type testing. Keep track of product approvals and Company's approved suppliers’ performance monitoring to ensure continuous product compliance to the intended specification. Corrective and preventive action process with supplier with CAR logging and follow-up for effective closure of complaints and issues related to product quality.

Knowledge in product testing and certification will be an added advantage.

Key Responsibilities:

1. Validate product quality conformance by conducting In-coming inspection and type testing for cable & accessories, include updating into SAP.

2. To be able to operate Laboratory test equipment for cable testing and accessories inspection

3. Understand international cable testing standards and inspection requirements with compliance to internal ISO procedures. Prepare test specification with detailed inspection requirement to be followed by the supplier.

4. Prepare and issue Customer test reports, certificates & COC

5. Track supplier quality by means of in-coming inspection or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined.

6. To generate supplier CAR and track for corrective action and effective closure of CARs by liaising with the supplier.

7. Liaising with relevant departments including suppliers to effectively close the CAR issued for Customer complaints or CAR’s which arise from internal findings (Z2 & Z8).

8. Maintain inspection records in SAP, determine skip lot and setup inspection requirements in SAP.

9. Assist Customer’s Technical enquiries e.g. Customer letter, RoHS, REACH & CE

10. Understand and comply with relevant ISO procedures, work instructions and corporate directives

11. Assist in other day to day activities related to QA department as assigned by superior.

12. Contribute to achieving company, department and personal KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification.

▪ Knowledge in ISO 9001:2015 QMS standard will be added advantage.

▪ To be able to operate lab equipment e.g. calliper, visual scope, resistance checker, High voltage tester etc.

▪ Prior experience in SAP system and knowledge of cable product testing is an added advantage

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

Mon to Fri 8.30am - 5.30pm

Objectives of the position:

This role is for the validation of Customer technical requirements by means of inspection of In-coming goods and release lots in SAP with defined usage decisions. Testing of ISIR samples (type test) for product approval process (power, control & data cable) with compliance to company standards and verify compliance to the international cable standards e.g. EN / IEC requirements. Understanding of each testing standards and be able to communicate the requirements to respective parties including suppliers. Establish test specification to be followed by suppliers. To be able to operate all laboratory equipment in the process of cable type testing. Keep track of product approvals and Company's approved suppliers’ performance monitoring to ensure continuous product compliance to the intended specification. Corrective and preventive action process with supplier with CAR logging and follow-up for effective closure of complaints and issues related to product quality.

Knowledge in product testing and certification will be an added advantage.

Key Responsibilities:

1. Validate product quality conformance by conducting In-coming inspection and type testing for cable & accessories, include updating into SAP.

2. To be able to operate Laboratory test equipment for cable testing and accessories inspection

3. Understand international cable testing standards and inspection requirements with compliance to internal ISO procedures. Prepare test specification with detailed inspection requirement to be followed by the supplier.

4. Prepare and issue Customer test reports, certificates & COC

5. Track supplier quality by means of in-coming inspection or arise from Customer complaints. Update results in SAP system and release inspected lots according to the usage decision defined.

6. To generate supplier CAR and track for corrective action and effective closure of CARs by liaising with the supplier.

7. Liaising with relevant departments including suppliers to effectively close the CAR issued for Customer complaints or CAR’s which arise from internal findings (Z2 & Z8).

8. Maintain inspection records in SAP, determine skip lot and setup inspection requirements in SAP.

9. Assist Customer’s Technical enquiries e.g. Customer letter, RoHS, REACH & CE

10. Understand and comply with relevant ISO procedures, work instructions and corporate directives

11. Assist in other day to day activities related to QA department as assigned by superior.

12. Contribute to achieving company, department and personal KPIs through due diligence, duty of care & personal accountability for Quality assurance in all tasks.

Skills & Qualification:

▪ Min. Diploma or Degree in Engineering (Electronics / Electrical) or equivalent

▪ Min. 2 years’ experience in electrical / electronic product testing and qualification.

▪ Knowledge in ISO 9001:2015 QMS standard will be added advantage.

▪ To be able to operate lab equipment e.g. calliper, visual scope, resistance checker, High voltage tester etc.

▪ Prior experience in SAP system and knowledge of cable product testing is an added advantage

▪ Good written and communication skills

▪ Good customer handling skills and able to communicate to all levels in the organization

▪ Proficient in Microsoft Words and Excel

▪ Addresses present issues immediately and independently

▪ Possess self-confident and willing to share opinions and expertise in discussions

▪ Anticipate potential problems and takes action to avoid crisis

▪ Provide support to colleague in the Department and work as a team to achieve Department goals and targets

RESPONSIBILITIES:

• Develop and update the quality material database and ensure proper recording and documentation
• Ensure proper documentation of raw materials/ ingredients/ finished products & traceability in place
• Liaise with regulators on mandatory requirements and compliance related matters
• To provide internal and external customers with technical advice and/or documentation when required
• Assist in the maintenance of HACCP and BRCGS management system

REQUIREMENTS:

• Diploma / Bachelor's Degree in Food Science or related field.
• Good knowledge of Quality Management System (HACCP, BRC, ISO 22000)
• Good communication, Organizational and Analytical Skills
• Able to work in a team and independently

Job Responsibilities:

• Management of Quality Management Systems.
• Support and maintain relevant systems both internally and externally.
• Responsible for Documentation Control system and Audits.

Job Requirements:

• Good working experience.
• Precision manufacturing industry.
• Adequate understanding of Quality Management System.
• Team player with good initiative and proactive.
• Microsoft office.

Job Responsibilities:
- Maintains the Company Integrated Management System, ensuring all business processes are documented, have a designated owner and a plan for their maintenance, aligned to Survitec strategy and associated accreditation and/or regulatory frameworks.

- Perform internal audit procedure and schedule as per Department audit plans, to include the audit Scope, Objective and Criteria. Deliver the audit report including findings; agree on corrective actions with auditees and refer findings to the Manager.

- Investigate non-conformances using current and appropriate methods, systems, and procedures, taking action to solve immediate compliance issues.

- Identifies shortcomings in quality processes or outputs, identifies root cause and works with internal stakeholder to adjust processes or working practices to remove or mitigate any production quality issues; uses established change management programs to address issues and deliver sustained improvements.

- Attend aviation related training and create/refresh and update on internal company aviation training notes.
Conduct internal company training as per aviation requirements.

- Implements systems to ensure compliance with QHSE policies, group and Customer requirements; ensures audit, inspection and risk management are adhered to and embedded throughout the system.

- Document control system management, revision and updating.

- Defines and communicates the processes and schedule for audit, working with colleagues from the Quality function to ensure all supplier, operational, technical, health, safety and environmental audit activity is carried out as planned.

- Leads and participates in quality, non-conformance and customer complaint investigations.

- Provides written reports on audit and investigation findings, implements and monitors CAPA and improvement actions. Ensures findings are reported and escalated appropriately.

- Works with Survitec QHSE colleagues to develop tools and dashboards for the statistical analyses on which recommendations for improvement are based. Ensures outputs from QHSE reporting tools and dashboards are communicated to and understood by the business.

- Inform manager of audit findings and compliance issues, including capability gaps, workflow issues or matters requiring quality development or improvement.

- Any others tasks/projects as assigned by line manager from time to time.


Job Requirements:
- Degree/Diploma in Engineering (preferably Quality Engineering).

- At least 2 years of Quality Assurance experience in Aviation industry.

- Knowledge of ISO 9001, ISO 14001, and TS 16949.

- Proficiency in statistical tools and Microsoft Office.

- Strong analytical, problem-solving, and communication skills
Certified Internal/Lead Auditor (preferred).

- Train the trainer qualification will have added advantage.

JOBSCOPE OVERVIEW

1. Represent QA/QC department in 2G Management Meetings or other meetings required by Directors.

2. Create and maintain standard operating procedure (SOP’s), protocols, guidelines that ensure consistency and efficiency throughout the QA cycle.

3. Acts as Committee of all ISO audits.

4. Supervise and manage QA/QC team and interns.

5. Conduct physico-chemical and microbiological test for Chemicals and Incoming Paper.

6. Liaise with suppliers and third-party agencies.

7. Provide technical support to the sales and marketing team regarding product specifications, sample requirement & others.

8. Document those methods in standard operating procedures (SOPs) and production records, quality assurance activities with internal reporting and audits.

9. Review and compile documents for Audits (Batch Record: Prod sheet, Quality control test Reports; FG and RM Reports, Mixing records).

10. Ensure that on time calibration program of equipment (mechanical and lab instruments, weighing scales and test weights) are executed.

11. Assist to do in compounding and mixing when Mixer Operator is on leave.

12. Liaise with Overseas factory (China and Indonesia) to ensure that product or service meets specified requirements.

13. Review method validation study reports, ensure proper documentation of findings, and assist in approval or re-validation recommendations. Prepare summary reports of validation activities, results, and recommendations for management review.

14. Investigate validation failures or deviations, identify CAPA, and ensure implementation. Collaborate with cross-functional teams to enhance the efficiency and effectiveness of validation activities.

15. Identify risks in testing methods, implement mitigation strategies, and ensure data integrity during validation to maintain accuracy, reproducibility, and regulatory compliance.

16. Review and approve method validation documentation, ensuring accuracy, completeness, and compliance with quality standards. Maintain up-to-date records of validation activities, deviations, CAPA, and ensure proper version control for all related documents.

17. Provide training on method validation processes and best practices, and support Production, QC and R&D teams in executing protocols and analyzing data accurately.

18. Any other area of responsibilities that the company deems necessary.

A. QUALITY CONTROL

1. Manage product complaints or non-conformances; thoroughly investigate process failure, determine the root cause, and take prompt corrective actions.

2. Conduct physical, physico-chemical test and microbial analysis of finished product.

3. Track the materials (chemicals and fragrance) that are present in the chemical room and know whether additional supplies need to be ordered.

4. Calibrate all equipment for In-house verification Example – pH meter, weighing scale etc. and arrange external calibration with external party.

5. Train new production operators in quality control.

6. Any other area of responsibilities that the company deems necessary.

B. LIAISE WITH SUPPLIERS (Services):

1. DI Water System Maintenance (Requirements: According to Contract): Loop Sterilization, UV-Lamp etc.

2. Complete Water Quality Testing (annual) by External Lab

3. Monitor the consumable supplies from different suppliers for DI Water (Column, filters, gauges).

4. Wet Wipes Monthly External Microbial testing

5. Monitor the annual cleanroom Certification.

6. External Calibration of Equipment

7. Any other area of responsibilities that the company deems necessary.

C. PRODUCT TECHNICAL SUPPORT

1. Support Export Sales and Marketing for preparation of documentation for regulatory use (COA, Ingredient’s list, FG and RM spec etc).

2. Collaborate with development, QC, and regulatory teams to plan, execute, and review method validation protocols, ensuring compliance with applicable guidelines (e.g., ICH, FDA, EMA) and company procedures, while meeting regulatory standards for intended use.

3. Support on the process validation on the manufacturing of the product.

4. Any other area of responsibilities that the company deems necessary.

General Responsibilities

• Ensure that all services provided by the centres meet or exceed internal standards and quality assurance guidelines.
• Conduct audits to ensure regulatory compliance, reviewing internal processes and procedures, and identifying high-risk non-compliance areas in line with regulatory standards.
• Participate in initiatives aimed at improving the quality of early childhood care and education at the centres.
• Ensure adherence to corporate identity and guidelines across all centres.
• Ensure that the team provides a safe, nurturing environment that fosters children's social, emotional, physical, and intellectual development.
• Promptly escalate any issues or concerns to management.

Licensing and SPARK Certification

• Familiarity with the ECDC Act.
• Familiar with the SPARK QRS-U framework.
• Ensure that all centres comply with regulatory standards.
• Develop action plans to meet Licensing and SPARKS criteria.

Policies and Procedures

• Oversee, track, and monitor the centres' corrective action plans, ensuring that principals, supervisors, and staff follow through and assess the effectiveness of these actions.
• Motivate the team to achieve operational efficiency, maintaining organizational capabilities without compromising quality standards.

Requirements:

• Diploma in Early Childhood Care & Education (ECCE) or a related discipline.
• Minimum 3 years of relevant experience in the field.
• Knowledge of quality/compliance management and early childhood regulations and standards.
• Experience with quality improvement systems.
• Strong analytical skills, attention to detail, and ability to review data effectively.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Preferably a Junior Executive specializing in Quality Control/Assurance or a related role.

We regret only shortlisted candidates will be contacted. All applications will be handled confidentially. By submitting your application, you agree to the collection, use, retention, and disclosure of your personal information to prospective employers.

Wecruit Pte Ltd

EA License No. 20C0270

Key Responsibilities

The successful incumbent will support the QA Manager in the following responsibilities.

• Ensure compliance with the Company’s food safety management system, QA standards, customer requirements, certification audits, and regulations for quality and food safety control processes.
• Support the Quality Assurance Manager (QAM) in preparing external and internal audits according to customer standards/contract requirements, and drive cross-functional teams to achieve targeted performance.
• Conduct site inspections to promote continuous improvement and adherence to Standard Operating Procedures (SOPs), hygiene, and food safety practices.
• Manage QA random sampling and microbiological testing for food samples, raw materials, water & ice, hand swabs, and Environmental Monitoring Program (EMP).
• Analyze data and follow up on unsatisfactory test results to identify potential causes of failure, recommend corrective actions for process improvement, and prevent recurrence.
• Prepare documentation related to all export matters in the capacity of Quality Person (QP).
• Develop training materials and conduct food safety trainings for operational staff.
• Review new product artwork to ensure regulatory compliance.
• Assist QAM in food safety incident management, including site investigations, testing, and preparation of incident reports.
• Support QAM in maintaining the ISO 22000/HACCP manual and QA documentation.
• Assist in the supplier approval program (supplier assessment/documentation review).
• Contribute to QA work plans and initiatives aimed at improving QA processes and food safety standards.
• Support Group QA, annual emergency exercises, and ad-hoc catering events as required.

Key Requirements

• Minimum Degree in Food Science/ Technology or other relevant fields.
• Minimum 2 year of QA experience in the food industry.
• Passionate in upholding food safety and possess good knowledge of Food Regulations, SFA requirements, GMP, and food safety management certifications (e.g., HACCP, ISO 22000, GFSI standards).
• Keen learning attitude, proactive, and decisive.
• Detail-oriented and meticulous with competency in report writing and presentation skills.
• Independent, committed and possess strong interpersonal communication skills
• Ability to multi task, handle stress in a fast-paced environment, and meet tight deadlines.
• Excellent interpersonal and communication skills.
• Collaborative and able to work effectively in a team.
• Must be comfortable working in a cold environment.

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Seletar
• Working Hours: 5 Days, Mon – Fri (9am – 6pm)
• Salary Package: Basic Salary (Up to $5,000) + AWS
• Duration: Permanent

Key Responsibilities

• Support the Manager in performing audits to ensure adherence to standards, including those under the Private Education Act, Private Education Regulations, EduTrust Certification Scheme, and Enhanced Registration Framework.
• Evaluate audit data to pinpoint performance discrepancies, observe trends, and assess process efficiency for ongoing enhancement.
• Work alongside departments to grasp relevant frameworks, organizational policies, and procedures, and suggest modifications.
• Discover opportunities for refining audit and/ or assessment processes.
• Other tasks as necessary.

APPLY NOW!!!

• Proficient in audit management, data analysis, quality assurance, and internal controls.
• Experience in Quality Assurance within a Private Education Institution (PEI) is an added advantage
• Familiarity with the Private Education Act, Enhanced Registration Framework, EduTrust Certification Scheme, and related standards is preferred.
• Excellent problem-solving, communication, and interpersonal abilities.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to [email protected]. Please indicate #71571 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

Job Scope

• Responsible to review and approve master batch records and subsequent batch records
• Review and approve cleaning records and procedures and ensure compliance with set
• Review and approve GMP documentation Ensure adherence to quality procedures, regulatory requirements and cGMPs.
• Review and approve deviations according to the site procedures
• Handle product complaints.
• Ensure complaints are investigated thoroughly with CAPAs effective to prevent recurrence.
• Coordinate with cross-functional team to prepare Annual Product Reviews, discuss trends and atypical observations and recommend improvement actions.
• Conduct internal and external audits
• Maintain inspection readiness and support inspections from regulatory agencies and customers.
• Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state.
• Support the maintenance of validated stated of GMP systems and processes.
• Facilitate and prepare regulatory submissions and attend to regulatory queries in a timely manner

Requirements

• Min Degree in Science / Chemical Engineering or equivalent with relevant pharmaceutical experience.
• Minimum 3 relevant years of experience in QA/QC and GMP Compliance
• Familiar with manufacturing operations applications; six sigma and lean principles and process improvement tools.
• Thorough knowledge of GMP compliance regulations, ICH Q7a Guidelines, Good Documentation Practices and other applicable regulations.
• Proven track record of continuous improvement in quality operations or manufacturing.

All qualified applicants, please send in your resume to: [email protected]

Alex Goh Hock Leong (R1763413)

Recruit Express Pte Ltd | Company Reg. No. 199601303W | EA License Number: 99C4599

Job Description

• Industry/ Organization Type: Education
• Position Title: Quality Assurance Executive
• Working Location: Seletar
• Working Hours: 5 Days, Mon – Fri (9am – 6pm)
• Salary Package: Basic Salary (Up to $5,000) + AWS
• Duration: Permanent

Key Responsibilities

• Support the Manager in performing audits to ensure adherence to standards, including those under the Private Education Act, Private Education Regulations, EduTrust Certification Scheme, and Enhanced Registration Framework.
• Evaluate audit data to pinpoint performance discrepancies, observe trends, and assess process efficiency for ongoing enhancement.
• Work alongside departments to grasp relevant frameworks, organizational policies, and procedures, and suggest modifications.
• Discover opportunities for refining audit and/ or assessment processes.
• Other tasks as necessary.

APPLY NOW!!!

• Proficient in audit management, data analysis, quality assurance, and internal controls.
• Experience in Quality Assurance within a Private Education Institution (PEI) is an added advantage
• Familiarity with the Private Education Act, Enhanced Registration Framework, EduTrust Certification Scheme, and related standards is preferred.
• Excellent problem-solving, communication, and interpersonal abilities.

Kindly apply through ANY of the following methods:

• Submit your application by clicking the APPLY button;
• Email your resume to [email protected]. Please indicate #71571 on the email subject.

Anradus Application Policy: We value each application and ensure every resume is reviewed. Our process is efficient, typically concluding within 3 working days. If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend continuing your job search to maximize your opportunities.

Anradus Pte Ltd | EA License No. 20C0161 | Adelin Chong | EA Reg No.: R1875641

We are hiring Contract Quality Assurance to be outsourced to our clients from reputable healthcare organizations.

Apply now!

Job Scope

• Support Validation Projects: Assist with qualification and validation activities, ensuring compliance with company procedures and regulations.
• Review and Approve Documents: Review and approve validation documents like protocols, reports, and procedures.
• Manage Discrepancies: Identify and address issues in validation protocols, ensuring corrective actions are documented.
• Act as Quality Representative: Participate in cross-functional projects as the Quality Systems and Validation representative.
• Provide Validation Expertise: Offer guidance on creating or updating validation documents, such as for analytical instruments and methods.
• Ensure Document Readiness: Ensure all qualification/validation documents are clear and inspection-ready.
• Support Ongoing Validation: Oversee the Master Validation Plan and support routine qualification activities.
• Collaborate Across Sites: Help standardize validation processes across multiple sites.
• Train and Coach: Develop training materials and provide support to team members and other departments.

Job Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Biology, Biotechnology, Chemistry, Chemical Engineering, Engineering, or related field.
• At least 2-3 years of experience in quality assurance, manufacturing operations, or validation in the pharmaceutical or biotechnology industry. Experience in equipment, process, cleaning, and computer systems validation is preferred.
• Strong understanding of FDA/EU cGMP requirements, including CFR 21 Part 11, and familiarity with PDA and ISPE GAMP guidelines.

All Interested candidates are invited to email your resume in MS Word format to:

[email protected]

Please include your full working experience, education background, notice period, expected salary.

Sheryl Tan
Outsourcing Team
Recruit Express Pte Ltd
Company Reg. No. 199601303W | EA License Number: 99C4599

We regret to inform that only suitable candidates will be shortlisted for an interview.

The primary responsibility of this position is to provide leadership for all Quality Assurance & Control matters.

This includes:

• Assuring consistent quality of production by developing processes and enforcing compliance to ISO 13485 quality system.
• Validating the production & inspection processes and maintaining validation status
• Managing the records for Quality Inspection, Quality Control, Calibration, QA Lab equipment, Training Resources, ERP Quality Module and Quality System Documentation.
• Managing a team of Engineers, QA Technicians & Quality Inspectors

The incumbent reports to the Site Leader, Singapore and Global Head of Quality (Medevio).

Roles & Responsibilties

Quality System Management

• Manage and maintain the site's quality management system (QMS) in compliance with ISO 13485 and ISO 9001 and applicable regulatory standards.
• Key stakeholder in ERP in Quality Module and DMS of site
• Ensure that the QMS effectively supports all manufacturing and operational processes, resulting in consistently high-quality product outputs.

Quality Operation & Lab Management:

• Oversee the day-to-day operations of the quality control and assurance, ensuring proper procedures and outcomes that consistently align with product specifications.
• Manage a team on quality inspection and establishing protocols fulfilling both internal, external customers.
• Develop and enforce rigorous lab testing protocols to maintain stringent quality and safety standards.

Capital Expenditure Planning and Equipment Management:

• Plan and manage capital expenditure for quality-related equipment in production to support ongoing and new operations.
• Site calibration SME and coordinator for both internal and external calibration.
• Ensure timely maintenance and calibration of quality equipment to maintain operational efficiency and compliance with industry standards.

NPI and quality engineering:

• Ensure compliance with new and pre-existing product requirements.
• Key stakeholder in new product development including qualification to production readiness.

Global Quality:

• Working with Global Head of Quality to drive Global Quality Plan
• Working with peers in Global Quality to drive strategic global initiatives, ensuring cohesive quality management across Medevio Sites

Regulatory Compliance and Auditing:

• Oversee readiness for all internal and external audits, including customer audits and third-party regulatory audits.
• Lead the preparation and submission of documentation required for regulatory compliance in all markets where products are distributed.
• Develop and implement strategies to manage and reduce compliance risks.

Supplier Management and Incoming Quality Control:

• Oversee supplier quality management, conducting audits and addressing issues to ensure supplier compliance with quality standards.
• Develop and maintain strong relationships with suppliers to ensure continuous supply chain improvement and adherence to quality specifications.

Quality Improvement Initiatives:

• Identify opportunities for process improvements and lead quality improvement projects to enhance manufacturing efficacy and product quality.
• Drive the transformation towards a paperless factory to enhance operational efficiency and data integrity.
• Implement Statistical Process Control (SPC) to monitor and control quality during manufacturing processes.
• Utilize digital tools and methodologies such as Six Sigma and lean manufacturing to improve productivity and product quality.

Team Leadership and Development:

• Manage and lead a team of skilled quality engineers and technicians, providing strategic direction, training, and development.
• Foster a culture that prioritizes quality and compliance through continuous training, learning and development programs, and succession planning.

Stakeholder Engagement and Reporting:

• Align with the global quality function on strategic global initiatives, ensuring cohesive quality management across the organization.
• Collaborate closely with manufacturing, R&D, and supply chain departments to ensure alignment on quality standards and to address quality issues promptly.
• Report on quality metrics and KPIs to senior management, providing insights and recommendations for ongoing quality enhancements.
• Communicate effectively with customers and regulatory bodies regarding product quality and compliance issues.

Complaint and CAPA Handling:

• Lead the investigation and resolution of non-conformance issues and product incidents, identifying root causes and implementing corrective actions.
• Manage the customer complaint process, ensuring all complaints are addressed promptly and effectively.
• Lead the development and completion of 8D reports, ensuring thorough documentation and effective resolution of issues.
• Oversee the implementation of corrective and preventive actions (CAPA) to eliminate the causes of potential non-conformities or issues, preventing their recurrence.

Environmental Health and Safety (EHS) and Sustainability:

• Support the development, implementation, and enforcement of an EHS policy, complying with all legal and corporate policies.
• Assist in fostering a culture of safety responsibility, providing ongoing training and resources to ensure a safe and healthy work environment.
• Support the establishment and execution of site ESG goals in alignment with Medevio's global sustainability roadmap, ensuring the site contributes effectively to broader corporate sustainability targets.

Qualifications

• Bachelor’s in Engineering or Science / Master’s in Engineering or Science
• Extensive experience within a manufacturing environment with a thorough understanding of ISO 13485 and ISO 9001.
• Six Sigma certification and/or ASQ certified Quality Engineer

Quality Assurance Manager (Biopharma/CBD/1 Year Contract)

Role Purpose:

The Responsible Person, Quality Assurance Manager Australia and New Zealand, will work collaboratively with relevant stakeholders to implement & maintain the local Australian and New Zealand QMS and will work with internal & external stakeholders to ensure quality requirements are met for organisation products, throughout the distribution network, and within Australia and New Zealand, all the way to patients.

Key Responsibilities:

• Establishes and maintains the Quality Management System in Australia and New Zealand to ensure that it meets local regulatory and industry standards and organisation expectations.
• Support maintenance of relevant licenses.
• Manages local process of change control, deviation, CAPA, complaint management and supplier management.
• Manages local Quality Management Review process.
• Participates in organisation’s Quality Escalation process for critical quality issues, and regulatory compliance issues.
• Ensures up to date organograms, training curricula pertaining to GMP/GDP, training records, CVs, and Job Descriptions are in place for local affiliate personnel working on quality/distribution matters.
• Establishes and maintains the Affiliate Quality Manual and GMP/GDP procedural documents.
• Establishes and maintains the Quality Agreement with 3PL/4PL and local GMP/GDP related suppliers/service providers, as required.
• Reviews Annual Product Quality Reports (if applicable)
• Ensures shipping conditions match the product license/product label particulars and transporters are appropriately qualified.
• Ensures premises and/or equipment used are reviewed regularly to ensure they are adequate to allow the handling, storage, and distribution of medicinal products in a manner that ensures the maintenance of product quality.
• Supports Customer Services with enquiries of a GDP nature such as delivery issues, transportation conditions, disputes, etc.
• Working with 3PL/4PL, provides guidance on supply related issues.
• Arranges authorized relabeling/repackaging in cooperation with 3PL/4PL (where applicable)
• Supports the management of quality and distribution complaints.
• Supports the investigation of fraudulent and counterfeit medicinal products.
• Manages product return and destruction.
• Manages local recalls and participating in supplier’s recall challenge or perform local mock recall, as needed.
• Qualifies and manages local 3PL/4PL and supports audit of 3PL/4PL.
• Qualifies and manages local GMP/GDP related suppliers/service providers, auditing and approving these according to local requirements.
• Assure customers validations and adequate records compliance to organisation QA requirements are established and maintained for all local distributors/customers.
• Collaborates with RA to support inspections and audits.
• Manages the Affiliate self-inspection program.
• Supports audit of distributor (where applicable).
• Collaborates with RA to implement activities for new product launch and product life cycle management.

Knowledge, Experience & Skills:

• Highly organized individual with a strong work ethic and ability to work flexibility and independently.
• Demonstrates proficiency in Good Manufacturing Practices (GMPs) and/or Good Distribution Practices (GDPs) and knowledgeable about the specific requirements for Australia and New Zealand.
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
• Demonstrates proficiency in Quality Systems processes (Deviation, CAPA, Change Control, Complaints, etc.)
• Demonstrates a knowledge of regional/local regulatory requirements and industry standards.
• Demonstrates strong verbal, written, and interpersonal skills in English.
• Demonstrates proficiency in Microsoft Office applications, particularly, WORD, Excel, PowerPoint, and Teams. Familiarity with technology platforms such as Veeva Vault, SAP ERP, etc.
• Working knowledge of Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA) is preferred.

Typical Educational Experience & Competencies

• Bachelors’ degree and 7+ years of relevant experience in a GMP or GDP environment-related field
• Masters’ degree and 5+ years of relevant experience in a GMP or GDP environment related field.
• Ability to work on own initiative as well as display strong teamwork skills.
• Demonstrates clear personal responsibility for own work, in terms of both the quality of the work and the manner in which it is performed. ‘
• Ability to support change and respond to change requirements by continually striving to improve working processes and systems, consistent with the organisational strategy.

EA License No. 01C4394 • RCB No. 200007268E •EA Registration No. R22109454 Malcolm Lee Jun Hao

By sending us your personal data and curriculum vitae (CV), you are deemed to consent to PERSOLKELLY Singapore Pte Ltd and its affiliates to collect, use and disclose your personal data for the purposes set out in the Privacy Policy available at https://www.persolkelly.com.sg/policies. You acknowledge that you have read, understood, and agree with the Privacy Policy.

Salling Search is currently recruiting for an experienced Quality Systems Manager for a reputable and established shipping company in Singapore.

Responsibilities

Quality Improvement and Monitoring

• Develop and implement a product quality improvement plan aligned with organizational goals.
• Monitor product quality metrics, analyze warranty data, and identify areas for continuous improvement.
• Conduct audits, assessments, and collaborate with suppliers to address quality risks.

Corrective and Preventive Actions

• Lead cross-functional teams to identify root causes of quality issues.
• Develop and implement corrective and preventive actions to mitigate future risks.
• Identify and communicate process and product improvements proactively.

Collaboration and Stakeholder Engagement

• Work closely with engineering, manufacturing, suppliers, and classification societies to ensure consistent quality.
• Build relationships with partners, customers, contractors, and official bodies.
• Liaise with shipyard personnel and management to ensure product quality meets organizational objectives.

Documentation and Compliance

• Develop and manage quality improvement documentation and reporting.
• Maintain a thorough understanding of product specifications, classification rules, and warranty claim processes.

Customer and Field Engagement

• Conduct customer familiarization with products and gather operational feedback.
• Travel occasionally to operational areas for fact-finding and quality assurance.

Professional and Interpersonal Skills

• Communicate effectively, build trust, and negotiate compromises when necessary.
• Stay updated on industry best practices and continuously develop professional skills.

Qualifications

• At least 6-8 years in management or supervision of marine vessel construction, operation, or maintenance with a proven track record.
• Formal marine or engineering qualifications are highly desirable.
• Strong negotiation, dispute resolution, and commercial acumen.
• Excellent communication and teamwork abilities.
• Proficient in managing documentation and records.
• A strong network of suppliers, subcontractors, and contacts is highly desirable.

Singapore

At Rolls-Royce, we pioneer cutting-edge technologies that deliver the cleanest, safest and most competitive solutions to our planet’s vital power needs. We embrace the power of data and technology and aim to be Digital First in everything we do.

Key Accountabilities

• To provide Quality and Safety leadership and expertise both internally and across the external Maintenance, Repair and Overhaul network for the APAC region to define and deploy strategies that drive quality improvement at pace.
• To provide Quality and Safety leadership to drive supplier maturity and improvement across the APAC region to deliver performance that enables the business to achieve its goals and enhance its reputation.
• Coach and lead suppliers to deliver an effective Zero Defects and Zero Harm strategy, underpinned by Quality Improvement Plans, whilst ensuring the Supplier has all the relevant prevention skills required.
• Development with the Supplier of their Quality Management System to ensure readiness for approval.
• Communicate a simple, compelling and consistent vision which suppliers understand and want to be part of.
• Engage and influence a wide range of people at all levels both internally and at Suppliers.
• Coach suppliers in complying with relevant requirements including MRO SABRe, Safety Management System and external / regulatory standards.
• Contribute to sourcing decisions by performing pre-selection assessments (ESSCA).
• Govern the delivery of the Quality performance (KPIs) of the aligned suppliers through performance and compliance monitoring to maximise efficiency and effectiveness in meeting requirements, business goals and enhancing its reputation. Where Quality performance diverges from target, drive and coach the suppliers on recovery.
• Protect the business and customer through performing, governing and coaching of problem containment and resolution methods and tools for aligned suppliers, to minimise impact and to ensure the necessary corrective and preventative actions are completed and verified in a timely manner. Ensure the effective governance of Problem Management exists in the aligned suppliers.
• Implement and ensure compliance to the SMT Operating System / Governance across the External MRO Network via implementation of a standardised Quality Governance across the MRO Network and in alignment with SMT priorities.
• Drive the deployment of the Supplier Maturity Assessment programme with identified Suppliers, by ensuring adherence to plan and a robust improvement plan is in place for each Supplier.
• Ensure suppliers self-lead improvement and engage appropriate internal and external resources.

Key Experiences and any Qualifications

• You will be Degree qualified or equivalent
• ​Demonstrated levels of leadership and influence
• Demonstrated MRO Part 145 knowledge essential
• You have demonstrated experience and track record of delivering results in a Quality Management role in an MRO Part 145 environment
• You can demonstrate good knowledge of relevant international standards or regulatory requirements
• You will have experience of root cause analysis, problem solving / 8D investigation methods and process improvement techniques.
• You will have experience in terms of containment activities and be able to provide regular updates to internal stakeholders.
• You will have a strong customer focus, able to effectively influence and challenge appropriately to manage customer expectations.
• Lean six-sigma Green Belt or Black Belt accredited, but not essential

Pioneer an enduring legacy. Join us and you’ll develop your skills and expertise to the very highest levels, working in an international environment for a company known the world over for brilliance and innovation.

Pioneers of Power

We are an equal opportunities employer. We’re committed to developing a diverse workforce and an inclusive working environment. We believe that people from different backgrounds and cultures give us different perspectives. And the more perspectives we have, the more successful we’ll be. By building a culture of respect and appreciation, we give everyone who works here the opportunity to realize their full potential.

You can learn more about our global Diversity and Inclusion strategy here.

So that you can be your best at work and home, we’ll consider flexible working arrangements for everyone, in any role. Click here for more details on how we can support you. Click here for more details on how we can support you.

Rolls-Royce follows a merit-based employee recruitment process and does not charge/accept any payment/security deposit from candidates during the recruitment process. Candidates seeking employment with Rolls-Royce should be cautious of potentially fraudulent communications and offers from individuals and agencies purporting to be from, or acting on behalf of, Rolls-Royce.

Please refer to the Career section on the Rolls-Royce website to verify employment offers or vacancies. Rolls-Royce shall not be liable for any loss, damage or consequences that may arise from any communication or offer of employment not directly made by Rolls-Royce.

Rolls-Royce reserves the right to take legal action against any individuals or agencies acting on behalf of Rolls-Royce without authorisation.

Authorities and Responsibilities

1. Responsible for providing directives for the Quality Assurance Department in meeting management objectives.
2. Formulate, implement and evaluate quality strategies programs for the company.
3. Implement and maintain a system of auditing the facility and periodic calibration of test, measuring equipment and tools.
4. Manage customer complaints, corrective and preventive action programs.
5. Administer and manage continuous improvement program for all QA processes.
6. Work closely with auditors, customers, production and suppliers to meet the quality requirements.
7. Manage sub-contractors for on-time supply of treatment process, as well as meeting technical requirement.
8. Review / prepare, administer and implement Quality Assurance Plans, Inspection Test Plans and other Operational procedures in accordance to the technical specifications, customer's surveillance requirements, and good manufacturing / engineering practices, and enforce the same on Operations in their execution.
9. Work closely among inter-department to ensure committed schedules are met in a timely and effectively manner.
10. Review and approve disposition program / action for nonconforming products.
11. Ensure that processes needed for the quality management system are established and implemented.
12. Report to top management on the performance of the quality management system, and note needed improvements.
13. Ensure the promotion of awareness of statutory, regulatory and customer requirements throughout the organization.
14. Ensure and coordinate the implementation of risk assessment and risk control of medical devices

The Quality Assurance Manager plays a crucial role in business by ensuring that products meet certain standards of quality. He/She plans, directs or coordinates quality assurance programs and formulate quality control policies. He/She also works to improve an organisation's efficiency and profitability by reducing waste. He/She prepares and update quality documentation, basing their processes on a recognised standard such as ISO 9000 – Quality Management, published by the International Organisation for Standardisation. He/She supervises teams of inspectors who carry out the detailed assessment of products and their components at different stages of production. He/She recruits and trains supervisors, and provides them with documented quality standards as guidelines for their daily work. He/She also selects quality inspection tools and software to support the inspection team.

Competence Requirements:

• Diploma in Mechanical Engineering / Quality Engineering or equivalent.
• Minimum 6 years of solid experience in Quality Management in similar or related industry and 3 years in management level.
• Good knowledge in implementing and up keeping Quality Management System.
• Strong leadership and good interpersonal skills.
• A team player with strong sense of responsibility to ensure plant effective quality performance.

~ Assist in the implementation of company quality systems.
~ Conduct Quality Assurance audit.
~ Manage cause investigation for non-conformance.
~ Manage company quality systems.
~ Manage departmental activities and deployment.
~ Able to commute between Tuas Plant and Loyang Plant.

Responsibilities (include but are not limited to):

· Work with the Manufacturing department as a production area Quality Assurance representative

· Coordinate and facilitate Quality Assurance related production and production related activities

· Ensure timely issuance of production records, procedures and labels

· Ensure timely assessment and closure of discrepancies, Deviations and Change Controls

· Review batch-related documentation, and ensure resolution of issues to release product

· Communicate lot disposition pending issues to Management

· Ensure approval and timely delivery of Final Product

· Ensure that products are manufactured in compliance with regulatory and GMP guidelines

· Review and approve Manufacturing and Validation documents for Regulatory and Kite compliance

· Review and approve Manufacturing Production Records

· Compile and verify all batch related documents into a Final Product lot disposition package

· Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues

· Review and disposition disposable raw materials and components for GMP use

· Review equipment and facility technical and investigation reports

· Review and approve proposed changes to systems, procedures, methods, and submissions to regulatory agencies

· Gather metric information for use in continuous improvement of areas of responsibility. Report to management as needed.

· Perform other duties as required

Requirements:

• Min Diploma / Degree in Chemical Process Technology, Foodscience, Biotechlonogy, Biology, Biomedical Sciences, Science or its equivalents
• No Experience Needed, Full training/ on the job guidance will be provided
• Able to start immediately

If you are interested in any of the positions, do kindly drop your most updated resume to [email protected] (Attn: QA Specialist)

Thank You.

Leon Leong De Cong
R1551708

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)
EA License: 99C4599

As a Non-Volatile Memory Quality & Reliability Assurance (NVMQRA) Engineer at Micron Technology, you will be responsible for performing formal Failure Analysis of customer reported failing devices via the Returned Material Authorization (RMA) process. You will be required to summarize lab analysis results at the electrical and physical level to identify root cause and establish an associated containment plan. In this role, you will have the opportunities to collaborate with various engineering and manufacturing stakeholders to evaluate and review Corrective Actions /Preventive Actions. You will provide documentation of the RMA findings and oversee the final customer report till closure. In addition, for the senior role, you will be asked to provide guidance and lead the team when solving complex unplanned deviations reported by our customers. Project management skills are necessary and the ability to make critical decisions that directly translate to quality and timely completion of the project is highly desirable. You will also be required to spearhead the sustaining efforts and keeping up to date on new product knowledge, as well as developing and mentoring new talents.

Responsibilities and Tasks

Perform Failure Analysis of Customer Returns

• Understand customer complaint of the memory component failure
• Initiate communication with Micron Customer-facing team for further details on customer complaint, requesting additional questions to provide best opportunity for successful analysis
• Perform bench level analysis including initial data image analyis/examination
• Perform Automated Test Equipment (ATE) analysis and interpret results
• Work with the appropriate engineering teams (e.g., PE, PYE) to perform detailed fault isolation when electrical failure has been confirmed
• Summarize findings and submit for physical failure analysis (PFA).

Provide FA Reports for Micron Customer Facing Team for Communication to External Customers

• Summarize analysis at electrical and physical level into customer friendly formats.
• Work with the appropriate manufacturing Global Quality teams through the appropriate request systems (example: GPSS) for Root Cause and/or Corrective Action and a containment plan
• Identify potential risk to external customers
• Communicate with respective BU (Business Unit) on potential impact to customers
• Communicate FA updates through interim reports or during scheduled meetings with the customers.
• Provide formal FA Report with findings

Sustain Knowledge of Device Capabilities and Characteristics

• Keep up to date with latest Fab/ASM process technology
• Understand datasheet specifications for each device and the differences from previous technode for NOR * NAND product family
• Comprehension of qualification data and potential impact to customer operation
• Stay up-to-date on common customer applications and usage model
• Partnering with customer support team to resolve ongoing customer issues

Qualifications and Experience

• Excellent verbal and written communication skills in English. The ability to communicate clearly and concisely both verbally and in writing is critical in this role.
• Good organization skills and ability to multitask and coordinate between multiple issue at any given time.
• Ability to work effectively in cross-functional teams and handle pressure situations in a professional manner
• Excellent problem-solving and analytical skills with strong attention to details.
• Familiarity with NexTest /Teradyne bench analytical tools, scripting in linux console will be an added advantage.

Candidates with 2-3 years of experience in the semiconductor industry as Product or QA engineer are preferred. Relevant experienced candidates will be considered for the Senior Role.

Education

A Bachelor or Masters Degree in Electrical Engineering or similar field of study.