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.

• Well Established Medical Devices Manufacturing Company
• Basic $2200 - $3000 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working hours: 12 Hours Shift

Job Responsibilities:

• Carry out inspection of incoming materials and finished products according to operational instructions to ensure that materials or products meet the requirements
• Ensure product identification is correct and stored in the correct location, maintenance of inspection equipment and daily monitoring of production environment
• Statistics on the quality status of incoming materials and processes and the quality of shipped products
• Assist in customer complaint analysis and take corresponding improvement measures
• Ensure records comply with good writing practice GDP requirements
• Assist the superior to complete other tasks

Job Requirements:

• At least 1 year of quality management experience and basic computer software
• Blueprint reading capabilities, and ability to use measuring devices like gauges, meters, calipers

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

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 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.

The summary of the scope of activity as below:

1. Revise and review SOPs

2. Review executed MBR/EBR

3. Support manufacturing team with any quality interpretation , queries and issues.

4. Provide quality oversight (participate GEMBA walk, GMP walk)

5. Perform archival of QO documents

6. Perform IQ and OQ. Involve in URS, design specifications

Requirements

• Min Degree in science / engineering related courses
• Min 2 to 3 exp of Quality experience from pharma / Medical industry
• Able to start work immediately

Up to $8K (For Senior role) x 1

Up to $6K (For junior role) x 1

Pharma MNC

Interested candidates, please forward your resume to [email protected]

Consultant: Huang Jingsheng Kevyn (R1333338)

Recruit Express Pte Ltd (99C4599)

Astek has an opening of Quality Engineer role for our projects in Singapore.

Responsibilities:

• Develop and maintain automated test cases, test plans, and test frameworks, ensuring alignment with evolving requirements and policy changes.
• Build, enhance, and manage the automated test framework and test environments.
• Execute testing on new features and document any defects identified.
• Conduct a variety of tests, including manual, functional, performance, and exploratory, while also supporting User Acceptance Testing (UAT).
• Assist in troubleshooting and resolving production issues.

Requirements:

• Bachelor’s degree in Computer Science, Information Technology, or a related field.
• 3-5 years of professional software quality testing experience, with hands-on automation expertise.
• Strong knowledge of testing methodologies, risk analysis, and test-driven development.
• Proficiency in Java or Kotlin, with Spring Boot knowledge a plus.
• Experience with automated testing frameworks like Cucumber, TestNG, Playwright, and performance tools like JMeter or LoadRunner.
• Familiarity with penetration testing tools such as ZAP, Burp Suite, and CheckMarx.
• Proven ability to work in SCRUM teams with excellent communication and collaboration skills.

• Well Established Company
• Basic $5000 - $6500 + Allowance + AWS + Variable Bonus
• Excellent Welfare and Benefits + Career progression
• Working location: Boon Lay
• Working day: Monday to Friday
• Working hours: 8.30am to 5.30pm
• QMS | ISO 13485 | Medical Devices

Job Responsibilities:

• Conduct assessment and review on supplier qualification, performance and process capability
• Ensure supplier quality issues are deal with, analysed, improved and follow through
• Collect, handle and follow-up on customer feedback/complaints
• Support internal, external and customer audits
• Evaluation, verification and validation of new parts/samples
• Establish and maintain inspection criteria for incoming, in-process and final products
• Identify quality issues, NCR, CAPA handling and drive continuous improvement
• Authorize the release (COC) of products, COA review & approval
• Monthly data analysis on product quality and quality objective
• Review and approval on DHR
• Participate in new projects, commercial product quality management and control
• Drive change management and control
• Other ad hoc duties as assigned

Job Requirements:

• Possess minimum Diploma/Degree in relevant subject area with 2 years’ experience in medical device QA and/or RA
• ISO 13485:2016 certified internal auditor will be advantageous
• Familiar with quality control tools

Candidates are encouraged to apply this position via Apply Now button with the following information in the resume

• Work experiences and job responsibilities
• Current and Expected salary
• Reason for leaving
• Date of availability
• Education background

We regret that only shortlisted candidates will be contacted.

LIONG ZHAO GUAN (R22107632)

EA Recruitment Pte Ltd

EA License No: 21C0492

Job description

Non-Destructive Testing (NDT) technicians examine structures,vehicles, and products for flaws and structural weaknesses usingnon-destructive testing techniques. They conduct material tests,interpret the results, and generate reports on their findings.

Requirements

Bachelor's degree in mechanical engineering, structural engineering,or a similar field.

Relevant NDT certification.

10+ years' experience as an NDT technician.

Advanced knowledge of NDT technologies including ultrasound,infrared, and radiographic.

Element has an opportunity for an experienced Quality Engineer. Reporting to the Principal Quality Manager, you are an essential member of the management team and responsible for the overall quality performance. This includes implementation, maintenance and improvement of Element quality management system (QMS). The successful candidate will have a sound working knowledge of ISO/IEC 17025, ISO/IEC 17020 or ISO/IEC 17065 requirements in relation to testing, calibration inspection and certification.

In this role, you will have interaction with clients, Accreditation Bodies and will be responsible for advising operational colleagues of the importance of quality, accuracy and integrity in the provision of the testing, calibration inspection and certification services we provide.You will be involved in leading quality at a local level and will work closely with the Principal Quality Manager to ensure that Element quality policies, processes and procedures are effectively implemented. As a quality leader within Element you will be capable of driving a culture of quality assurance and quality improvement, working closely with your operational colleagues and the wider Element quality community.

This role is based in Sungei Kadut Loop, Singapore.

Job Duties:

• Ensuring all staff buy-in to the effective and efficient implementation of Element quality policies and procedure by providing advice, guidance and support on quality issues to Element Singapore and Malaysia business units.
• Driving quality improvements at every opportunity and proactive participation in continuous improvement and process improvement projects and ensure effective adoption of Element e-QMS throughout Element Singapore and Malaysia business units.
• Proactive participation in projects to deliver identified Quality objectives and contribute to and drive key initiatives to improve Quality awareness and compliance.
• Management of and participation in scheduled internal audits across management system and technical disciplines and proactively monitoring laboratory test equipment for calibration currency and advising management of upcoming schedules,ensuring corrective and preventive actions identified within specific laboratories are implemented and verified in a timely manner.
• Represent Element Singapore and Malaysia business units during assessments by accreditation bodies and audits by clients and controlled document holding and arrange to update appropriate documentation as necessary, control and issue of Element Singapore and Malaysia Quality Management Systems documentation and participate in the internal audit programme to monitor implementation of quality policies and procedures.
• Manage external and internal proficiency testing programs of all Element Singapore and Malaysia business units and prepare compliance and improvement metrics for Element Singapore and Malaysia business units quality as required.
• Writing and reviewing quality documentation as required and effective and efficient management of personal work schedules and timely generation of Element Singapore and Malaysia business units quality reports.

Job Requirements:

• Minimum Bachelor of Science or Engineering qualification.
• Proven experience (minimum two years) of managing quality management systems within a multi-discipline testing, inspection and certification environment, preferably multi-location.
• Demonstrable experience auditing against ISO/IEC 17025, ISO/IEC 17020 and ISO/IEC 17065.
• Sound knowledge of equipment calibration and analysing proficiency test data.
• Knowledgeable in uncertainty of measurement and risk assessment and hands-on experience with Element e-QMS preferable.

HOW TO APPLY:

Interested applicants, please submit your updated resume to [email protected]

Please state your availability, current & expected salaries for processing purpose. All applications will be treated in the strictest confidence. We regret that only shortlisted candidates will be notified.

• MEP Contractor
• Basic up to $5000
• Office hour 6 days
• Bus from MRT Pioneer

Job Responsibilities:

• Oversee quality checks for incoming, in-process, and outgoing products, ensuring adherence to inspection criteria, quality plans, and finishing work per method statements.
• Work with QA, Process, Engineering, and Product teams to address quality issues, perform audits, and implement corrective actions.
• Manage and control supplier quality standards, ensuring compliance with required specifications.
• Prepare inspection reports, coordinate site visits, and liaise with Project Managers, Engineers, and Authorities for certifications.
• Provide training to workers on method statements and ensure compliance with construction and quality standards.

Job Requirements:

• Minimum ITE, Diploma, or Degree in Manufacturing or Quality Engineering.
• Preferably at least 2 years of experience in a Product Manufacturing environment.
• Knowledge of ISO standards (9001, 14001, 13485, 45001) is a plus.
• Understanding of quality requirement of DMA Modular Prefab MEP product, Materials Selection, Fabrication, Assembly and Inspection will be an advantage.

For consideration, kindly submit your CV by clicking “APPLY NOW” or email to [email protected] for confidential discussion.

*Only shortlisted candidates would be notified**

MTC Consulting Pte Ltd | 15C7752

EA. Registration No.: R24124448 | Nana Yeoh Li Xuan

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

- 1 year renewable contract

- Up to 3,000 + PB

- Monday to Friday: 9am – 6.30pm

- Novena

Responsibilities:

• Deliver Quality Assurance objectives by conducting regular call reviews and highlight any potential risk to management.
• Review 15 of closed sales calls per day for General Insurance Team.
• Backup for Auto Insurance for Call Review purposes.
• Promptly report any calls detected with potential quality issues (e.g. misrepresentation, fraudulent) to Management.
• Prepare, track and send Quality Assurance related reports to UOB management and team. (NMD, Service Quality Monthly, Penalty Points Table)
• Keep track on all the status of Quality Assurance Cases from beginning to end process and provide update to management on a timely manner.
• Weekly meeting with management to discuss on discrepancies and solutions for further improvements.
• Other ad-hoc duties as assigned by supervisor

Period:

• 1 Year Renewable Contract

Location:

• Novena

Working Hours:

• Monday – Friday (9.00am – 6.30pm)

Salary:

• Up to 3,000 + PB

Requirements:

• Good to have BCP and PGI Certificates.
• Preferably have quality assurance experience and insurance products knowledge.
• Meticulous and responsible team player.
• Proficient in Microsoft Office.
• Able to multi-task.
• Fast Learner and willing to learn on multiple Insurance Products.

Interested applicants, kindly email your detailed resume (MS Word format is preferred):

[email protected] (Reg No: R1549023)

Please ensure that applications sent through email are no bigger than 1Mb.

We thank all applicants for your interest but regret to inform that only shortlisted candidates would be notified.

Success Resource Centre Pte Ltd (EA License Number: 04C3201)
160 Robinson Road, #13-07/08/09 SBF Center, Singapore 068914

T: 6337 3183 | W: www.successhrc.com.sg

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

Our client is a global leader in the pharmaceutical industry, dedicated to improving health and well-being through innovative medicines and healthcare solutions.

They seek a Regional QA Specialist to lead regional internal and external audits for their external/contract manufacturers and suppliers, ensuring compliance with regulatory standards and upholding high-quality pharmaceutical, medical devices guidelines and requirements.

Key Points:

• New headcount with growing, reputable pharma MNC
• 5-day work in CDB area with hybrid work arrangements, near MRT
• Overseas travelling opportunities with attractive salary and perks

Responsibilities:

Uphold quality standards and activities of regional external/contract manufacturing organisations, ensure adherence to relevant international regulations, guidelines and industry practises alongside company compliance requirements.

• Perform internal and external audits (supplier or EMO/CMO) audits and assessments to evaluate compliance with quality standards and contractual requirements.
• Monitor EMO/supplier qualification, assessment and performance evaluation processes.
• Develop update and maintain Quality and Technical Agreements with current GxP guidelines.
• Maintain and update internal audit program.
• Plan audit schedules and facilitate process for audit findings to be resolves and all change implementations to be fulfilled with defined targeted datelines in compliance to GMP and company SOPs.
• Proper records and documentation in accordance with regulatory guidelines such as GMP document, site master files, quality manual and agreements.
• Establish and maintain QMS to ensure content compliance to all regulations and company practises, overseeing Validation QA.
• Provide training and guidance to quality staff on quality documentation, including system – Veeva (QMS), compliance training system etc.
• Collaborate with quality team and carry out assigned quality audit activities for continuous improvement throughout the organization.

Requirements:

• Bachelor's degree in a Chemistry, Pharmacy, or a related discipline; preferred Science or Engineering.
• Minimum of 5 years of experience in pharmaceutical or medical device industry, including 3 years in relevant quality compliance and audit roles.
• Experienced in auditing, especially with experience managing overseas EMO/CMO/third party manufacturing experience is highly preferred.
• Strong GMP, Computer system validation, deviation management, CAPA, change control and documentation management in pharmaceutical / medical device MNC environment.
• Demonstrate pro-activeness to drive results even amidst crises and ambiguity, thriving in fast-paced and dynamic environments.
• Successful proven track records of implementing continuous improvement projects with regional teams to enhance overall business operations.
• Possess strong cross-functional collaboration skills and adept stakeholder management capabilities. Skilled in building and maintaining relationships at all levels, both internally and externally.

NOTE: Position title may change based on candidate's experience, qualifications, and company structure at time of offer. This is to ensure alignment with candidate and organizational needs.

The selection process involves careful consideration, and only shortlisted candidates will be contacted. We extend our gratitude to all applicants for their interest and effort in applying.

Principal Consultant: Amber Chen | Registration Number: R22108633 | EA License Number: R1110404

• Drive quality culture and promote GMP compliance behaviors to the site.
• Ensure site compliance to Quality Standards (QS) and ICH guidelines.
• Provide QA oversight to the site GMP operations to ensure products produced in compliance with the Quality Standards (PQS).
• Collaborate with cross functional teams to improve quality systems.
• Understand regulatory expectations and support site inspection readiness.
• Work with supply chain and drug product sites to ensure timely delivery of quality products.
• Work with GCMC to file products and address regulatory queries in an accurate and timely manner.
• Require working on rotating shift.

For interested candidates, please send your updated resume:

Email: [email protected]

Whatsapp: 96503173

Telegram: @jesswongie

Jessie Wong Yuan Si

R2197171

Recruit Express Pte Ltd (Healthcare & Lifesciences Division)

EA License: 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

Responsibilities

Quality Assurance:

• Overall implementation and maintenance of the Quality Management System (QMS) in compliance with ISO 13485 and 21 CFR 820 standards.
• Ensure all departments carry out due processes and documentation required to ensure conformance to the QMS, including design & development, production and software.
• Conduct internal audits and lead external audit preparations.
• Conduct Management Review, onboarding training for new employees, and company-wide refresher training
• Collaborate with cross-functional teams to address non-conformances, CAPAs, and continuous improvement initiatives.
• Participate in risk analysis and management activities to ensure compliance with ISO 14971.
• Support post-market surveillance and vigilance reporting activities.

Regulatory Affairs:

• Preparation, submission, and maintenance of regulatory documentation for market approvals in regions including Singapore, US, Malaysia, and Australia.
• Monitor and interpret regulatory updates and standards relevant to medical devices.
• Ensure labeling, packaging, and promotional materials comply with regulatory requirements.
• Collaborate with the R&D and manufacturing teams to ensure product compliance during development and production phases.
• Maintain accurate and organized records to support regulatory inspections and audits.

Minimum Skills and Requirements

• Bachelor’s degree in Engineering, Science, or a related field.
• Ability to work independently and cross-functionally with different teams
• Strong organizational and analytical skills.
• Effective communication and teamwork abilities.

Advantageous Skills

• Knowledge or experience with regulatory submissions to Malaysia MDA, Australia TGA, US FDA, and Singapore HSA.
• Familiarity with ISO 13485, ISO 14971, and other relevant standards.

• 5 days work week
• Location: North

Job Scope:

• Take charge of our Integrated Management System, ensuring processes are documented, owned, and regularly improved.
• Lead internal audits by preparing schedules, conducting audits, reporting findings, and implementing corrective actions.
• Investigate non-conformances, pinpoint root causes, and implement effective solutions to enhance operational quality.
• Oversee compliance with QHSE standards, ensuring alignment with industry and customer requirements.
• Manage document control systems, keeping records accurate, up-to-date, and aligned with regulatory needs.
• Conduct internal training to ensure the team stays ahead in aviation-related standards and practices.
• Collaborate with cross-functional teams to monitor and report quality metrics, driving data-driven decisions.
• Lead quality investigations, identify improvement opportunities, and escalate key findings to management.

Job Requirement:

• A Diploma/Degree in Engineering, preferably in Quality Engineering.
• At least 2 years of hands-on Quality Assurance experience in the aviation industry.
• Proficiency with ISO standards (ISO 9001, ISO 14001, TS 16949) and statistical tools.
• Strong analytical mindset with excellent problem-solving and communication skills.
• Internal/Lead Auditor certification (preferred) and a passion for knowledge-sharing (Train-the-Trainer qualification is a bonus).

To Apply, kindly click on the "APPLY NOW" button

We regret that only shortlisted candidates will be notified.

Staffking Pte Ltd (20C0358) | Chong Kar Ming (John) (R21101412)

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

• Position: Quality Assurance QA/QC Engineer (MUST BE from Marine Engineering)
• Location: North Bridge Road (Walking distance from Fort Canning MRT Station)
• Working hours : 5 days / Monday - Friday - 9.30am -5.30pm
• Salary (Commensurate with experience): Basic up to $ 3700 + AWS + 14 days Annual Leave
• Duration : Permanent
• Industry : Global leader in Marine Lifting Equipment

Main Responsibilities:

• Perform inspection of incoming products, materials or customer items according to job project requirement
• Perform initial inspection and raise report
• Perform in-process inspection according to procedures and customer’s specifications. Raise report whenever necessary. Measure and record the dimension of components/parts using measuring instruments and analyse the findings for discrepancy
• Perform final inspection of items including dimensional and NDT to ensure that all quality requirements has been achieved. Analyse result and decide the acceptance level of the final product
• Prepare and conduct Project Specific Quality requirements training to production Supervisors and Sub-contractors QC Personnel.
• Establishing Work Procedures and Instructions.
• Support QA/QC Manager for establishing WPS, PQR and WQT Qualifications.
• Act as Project Lead QA/QC and control the entire project Quality Assurance and Control activities during construction phase.
• Oversees the Inspector’s performance on the project towards monitoring and control of workmanship towards quality.
• Updating of Inspection status and records on daily basis.
• Attend weekly client progress review, Internal and Sub-Contractors meeting to discuss Quality issues.
• Liaise with client in relation to Quality on Project Specific.
• Schedule and conduct Project Specific Quality Audit as per agreed Plan.

Requirements:

• Degree in Engineering or Diploma in Mechanical/ Marine Engineering or equivalent
• Experience in handling project Audit and liaise with internal & external auditor
• Knowledge in structural fabrication, piping isometric drawing and materials
• Experience in piping line walk, reinstatement inspections by clear understanding of isometric drawings

Email to: [email protected] or call me at: 6398 5689 for more information.

Like us on Facebook or Instagram (For Career tips and Job vacancies): www.facebook.com/search.personnel / https://www.instagram.com/search.personnel

Join us on Linkedin: www.linkedin.com/company/search-personnel-pte-ltd

***We do not charge our candidates any referral fee nor bind them with any contract.***

Jane Chua

Associate Consulting Director (APAC)

License no: 13C6684

EA Personnel: R2197224

Thank you for your interest in this position. Our shortlisting period is 3 working days. Only shortlisted candidates will be contacted for further consideration.

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 that you continue your job search to maximize your opportunities. We wish you all the best and should we have any suitable roles that match your experiences/ qualifications/ preferences, we will reach out to you.

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.

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

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.