Total 20 quality assurance manager job vacancies in Quality Assurance / Control category in nlb library supply centre changi

Job Description:

1. Performing general inspection of parts and products at the Incoming/In-Process/Outgoing gate.
2. Generate Standard QA/QC inspection report.
3. Administrative tasks.
4. Logistics support.

Competence Requirements

• Preferred Secondary, NTC certification holder from related CNC/Fabrication industry.
• Preferably with 2 years of related work experience in manufacturing environment for non-technical trained staff.
• Able to read part drawing, usage of measuring equipment are added advantage.
• Computer competency.

Duties and Responsibilities:

a) Monitor compliance to airworthiness regulatory requirements and quality standards

b) Conduct of internal quality audits and vendor audits

c) Facilitate training on regulations and quality related subjects

d) Support Safety Management System program

e) Perform capability evaluation reviews

f) Administrate personnel authorisation approval

g) Conduct quality investigation, analysis and drive corrective actions

h) Maintain Quality related KPIs

i) Comply with Health, Safety and Environment (HSE) regulations as prescribed by local law and company’s policies.

j) Participate and contribute to HSE initiatives & Corporate HSE programs and in HSE risk communications & mitigations.

k) Support to in Continuous Improvement Program

l) Any other duties as assigned

Experience and Qualifications:

a) Diploma / Degree holder in mechanical / electrical / electronic engineering or equivalent

b) Relevant CAAS papers qualification or equivalent will be advantageous

c) Minimum 2 years relevant working experience in aviation field is preferred

d) Knowledge on airworthiness regulatory requirements and AS9110 Standards

e) Trained Internal Quality Auditor / Lead Auditor is preferred

f) Safety Management System trained will be an added advantage

g) Good communication and writing skills

h) Knowledge in MS Office (Excel, Word, Powerpoint, Power BI), SAP, etc

i) Willing to work excess hours when required

j) Able to do business travel in short notice

k) Possess knowledge of statistical tools and methodology

l) Good team player and ability to handle tight datelines

Jetstar thrives on innovation. We are always looking to employ ambitious, proactive team-orientated professionals to help our business work smarter and more efficiently. You will be encouraged to think innovatively whilst developing and maintaining best practice.
Reporting to the Manager, Flight Operations, you are fully accountable for ensuring flight operations compliance activities are monitored and achieved within acceptable time frames.

Other Key responsibilities of this role are:

• Responsible for the oversight of all Compliance activities affecting flight operations.
• Responsible to analyse the effectiveness of all Civil Aviation Regulations issued by CAAS and make sure all operational manuals and standards/procedures in accordance with regulation by working across all operation department.
• Responsible for internal /external audit of compliance and flight operations and evaluate aircraft performance factor and fuel/ weight & balance analysis.
• Responsible for Ops-Engineering related project and issues.
• Responsible for Flight Ops EFB and related fuel/cost saving projects
• Overall in charge of AAMP-internal testing and CORSIA management:

To be successful in this role, you will need to demonstrate the following skills & experiences:

• Minimum 3 years of airline experience
• At least a university degree in Engineering or Aviation
• Possess job knowledge from previous airline in a similar related position.
• Possess strong commercial acumen with analytical and problem-solving skills
• Result oriented with excellent communication and interpersonal skills.
• Attention to details
• Ability to think technology for process improvement and change management

Please note that only shortlisted candidates will be notifie

Responsibilties

• Collaborate with the Resident Manager & Assistant Managers to establish standard operating procedures for ground operations.
• Inspect daily tasks performed by ground staff.
• Employ a coaching approach to reinforce SOPs with ground staff: supervisors and housekeeping staff.
• Mentor new staff during orientation.
• Implement skills enhancement programs for ground staff to boost performance.
• Update training schedules for cases of non-conformance and monitor improvements to bridge skills gaps.
• Coordinate and conduct training sessions on safety, quality, and environmental subjects.
• Undertake any other assigned ad-hoc tasks by the Manager.

Requirements

• Minimum Diploma/Degree in a relevant field of study and be open to training.
• 2 years of experience in conducting QA/QC checks.
• Proficient in Microsoft Office applications (Excel, Word, etc.).
• Capable of working independently and thriving under pressure.
• A team player who can handle multiple tasks in a fast-paced setting.
• Willing to work shifts and overtime occasionally.
• Good communications skills are preferred.

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EA License No: 19C9950

EA Personnel: Pang Seng Leng Diana

EA Personnel Reg No: R1106651

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.

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.

Job Description

To perform inspection by using CMM & other measuring equipments

To ensure parts are according to customer's requirements

Job Requirements

Higher NITEC level in technical engineering or GCE 'O' level

Minimum 1 year related working experiences

Able to operate CMM machine independently is an advantage

Able to commit overtime

Good team player

Independent

Duties and Responsibilities

• Implement, maintain, and continuously improve on the Quality Management System.
• Assist in ensuring company and business units comply with the company’s standards, customer requirements, local statutory regulations, and International Air Transport Association (IATA) standards.
• Monitor and ensure all company documentation aligns with dnata Documentation System Standards.
• Monitor the accessibility and dissemination of all airline customer manuals to stakeholders.
• Lead the quality assurance program to ensure operations follow standards.
• Plan and conduct annual internal audits with qualified auditors for business units and contractors.
• Plan, schedule, and conduct inspections for the company via the d-auditor tool.
• Review work processes and workflows to improve operational effectiveness and meet KPIs.
• Facilitate external audits with stakeholders and monitor corrective and preventive measures (accreditation ISO 9001, ISAGO, and Airline Station Audits).
• Analyze and prepare data from audits, compliance checks, or other areas as requested for management reporting.
• Collaborate with HQ on projects (e.g., dnata hub modules) as part of continuous improvement.
• Support and assist in workplace incident investigations (if required).
• Review and update the corporate management manual and implement solutions to resolve quality issues.
• Support departments assigned to the company’s Crisis Management Plan.
• Ensure compliance with all workplace safety, security, and health policies and procedures.

Requirements

• Minimum Degree/Diploma in Aviation Management from a recognized tertiary institution.
• Minimum 10 years of working experience managing Quality Management Systems, preferably in airline or aviation services.
• Working knowledge of ISO 9001, ISAGO, and experience in audits.

Duties and Responsibilities

▪ Be the driver in providing direction and the implementation of the company’s quality system.

▪ Review statistical data, analyse and recommend changes to production processes or quality controls to prevent future occurrence.

▪ Analyse records of product returns to identify specific problems or trends over time and work with internal team to find long term fix to the problems

▪ Develop and monitor continuous improvement programs, aiming to reduce the number of defects and improve quality levels.

▪ Works with suppliers to help formulate quality standards to ensure that incoming components and materials will comply with the manufacturer’s quality standards, minimizes the time and cost of inspection, and contributes to the quality of the finished product.

▪ Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; participating in professional societies.

▪ To ensure that employees working in production are aware of quality requirements, provide training in best practices. Promote a culture of quality, run awareness and award programs.

▪ To have good knowledge and understanding of quality management system, environmental and health standards.

▪ Maintains and improves product quality by completing product, company, system, and compliance audits.

▪ Maintains and prepares quality documentation and reports by collecting, analyzing, and summarizing information and trends.

▪ Trains and motivates employees to ensure that quality standards are met.

▪ Able to communicate with all levels and departments within and outside the organisation.

▪ Be the company’s Management Representative on all audit and quality matters.

Management Responsibility

The Senior Quality Manager leads the Quality team. Responsibilities for this include:

• Setting the Quality culture and strategy for the Denselight, plan training strategy, direction, and priorities of the Quality team.

• The creation of the environment for the Quality team to succeed.

• Addressing any Quality issues in an appropriate manner.

• Team management activities including team personnel administration and training-related activities.

Key Stakeholders and Relationships

Some of the key stakeholders and relationships for this role are:

• Top Management, to ensure that Quality initiatives are understood, communicated, approved and endorsed before implementation.

• Head of Departments (HOD), to ensure any risks or issues identified by assurance activities are proactively mitigated with improved processes, procedures and ways of working.

• Senior Project Managers and Project Managers, to validate that quality arrangements support effective project execution.

• Human Resource, to leverage the opportunities for continuous improvement, lessons learned, innovations and knowledge to develop a robust quality approach to the programme

• Sales & Marketing, to ensure that the quality of technical deliverables is supported to internal and stakeholders’ standards.

• Technical Marketing, to ensure that designs and technical information are being delivered in a manner that supports right-first-time delivery.

• Contractor(s), to validate and verify that works are being delivered in a manner that supports right-first-time delivery and the programme realising its strategic themes and goals.

• Head of Information Management, to deliver an Information Management framework to the organisation that is efficient and effective and meets the needs of all its stakeholders.

• Others as necessary

Qualification Guidelines

Minimum Education

Bachelor’s Degree

Minimum Experience

Minimum 10 years’ experience in QA systems implementation and management in a medium-size manufacturing environment

Specific Knowledge / Skills

• People Management
• Analyzing Information
• Reporting Research Results
• Technical Understanding
• Promoting Process Improvement
• Developing Standards
• Managing Processes
• Manufacturing Methods and Procedures
• Dealing with Complexity
• Problem Solving
• Process Improvement

Roles and Responsibilities

• Design, maintain and administer the Company's quality training programs.
• Prepare curriculum, training material and recurrent training material to a defined standard.
• Teach formal classroom training courses such as but not limited to policy, procedures, maintenance paperwork, safety, Human Factors, airworthiness regulations, recurrent training and other subjects.
• Revise training curriculum and serve as subject matter expert.
• Design, maintain and administer GE Aviation – Singapore’s Quality System.
• Initiating, updating and maintaining QCWIs and other quality documents as and when required.
• Be in control of the Technical Library. Assure all data are up-to-date and that revisions are distributed to all Engineers affected.
• Facilitate all regulatory and customer audits, work with the appropriate functions in the formulation of corrective actions.
• Support the training and qualification of Certifying Staff.
• Be responsible for the archival of maintenance records. Supervise a team of Technicians in the scanning of maintenance records and ensuring the operability of the scanning equipment.

Required Qualifications

• Degree in Engineering
• 3 or more years of Experience with Quality Systems
• Certified Part 145 or equivilant
• Minimum 2 years of aerospace experience in repair/manufacturing or a quality assurance role.

Desired Characteristics

• Holds a recognized Lead Auditor or Internal Auditor certification.
• Knowledge of Quality Systems/ISO/Aerospace Standards.
• Possess CAAS Air Legislation paper.
• Knowledge of basic engineering and aircraft engine component repair.
• Good auditing experience.
• Good command of written and spoken English.
• Basic knowledge of PC software.
• Good initiative and analytical skills.
• Strong attention to detail and accuracy.
• Ability to communicate at all levels of the organization.
• Demonstrate oral and written communication skills.
• Strong interpersonal and leadership skills.

About the Job

The Quality Department plays a very important role in Cyrus in maintaining the quality management system and driving quality improvements to deliver high quality products for our customers. You will be working closely with the Assistant Quality Manager on Quality Management System (QMS) and suppliers’ management.

Your key responsibilities are as follows:

- Maintain updated and accurate documents and records on ISO 9001, 14001 and 13485 system (includes Quality Manual, Procedures, Work Instructions, Forms, etc.) to ensure system compliance and ready for Management Review.

- Plan and conduct internal and external audits to ensure readiness of all sections for third party certification body, management review and customer audits.

- Coordinate with internal stakeholders to participate in customer or supplier audits for compliance

- Review audit findings and develop action plans to drive continuous improvements.

- Generate and review quality reports on suppliers’ performance and work with suppliers to address non-conforming materials, and drive for continuous improvement.

- Issue and follow up on Supplier Corrective Action Request (SCAR) to suppliers, monitor and review SCAR effectiveness for timely closure.

- Support the qualification of new suppliers to maintain a healthy pipeline of qualified suppliers to meet Cyrus production requirements.

- Maintain and conduct regular review of calibration and preventive maintenance for equipment.

- Responsible for quality issues arising from production and customer feedback, and collaborate with the production team to address internal process issues and implement corrective actions to resolve customer complaints with proper documentation.

- Responsible for timely closure of Corrective and Preventive Actions (CAPA), non-conformance investigation report and customer complaints and, publish reports on quality performance.

- Lead the Material Review Board (MRB) meeting involving members from production, engineering and quality departments to conduct root cause analysis, address quality issues, implement corrective actions and review its effectiveness.

- Lead the team of QC inspectors in the inspection of parts for conformity in accordance with relevant drawing requirements.

Your areas of knowledge and expertise that matter most for this role:

· Diploma in quality management / Engineering / Manufacturing or related field

· Minimum 3 to 5 years of relevant working experience in handling audits and ISO documentation in manufacturing industries.

· Knowledge in Supplier Management

· Knowledge of quality Management Standards such as ISO 9001, 14001, 13485 and ISO 22301.

· Knowledge in Potential Failure Mode Effect Analysis (PFMEA), Control Plans .and Gage Repeatability & Reproducibility (GR&R)

· Familiar with 8D and 5W problem solving methodology.

· Good communication and presentation skills

· Organized and detail oriented.

· Positive attitude with ability to multi task.

· Independent, takes initiatives and able to work with minimum supervision.

· Good team player with good initiatives and ability to work independently.

Responsibilities:

• Perform internal audits as per internal audit schedule in accordance to AS9100, and PART-21 Subpart G requirements OR AS9110C and P-145 requirements
• Manage the qualification and authorization of Technician, Inspector and Signatory (APU)/ Certifying Staff (ARU)
• Facilitate training management, by doing operator audits, manage operator certifications, stamp register control, product authorization matrix, and follow up of re-certification
• Support external audits, (Civil Aviation Authorities, customers and Certification bodies)
• Facilitate and participate in Analysis and Decision committee / Material Review board, related to product non conformity. (APU)
• Manage and update Quality procedures in the Quality Management System
• Validate the qualification of new test equipment
• Participate and contribute in Production Readiness Reviews
• Perform training on Quality related topics for staff
• Manage the internal production or repair quarantine.

Requirements:

• Degree/ Diploma in Quality, Quality Management or Mechanical Engineering or Electrical Engineering or Electronic Engineering or Equivalent
• Minimum 3 years of experience in Avionics Workshop Maintenance Environment/ Electronics Workshop / Mechanical Workshop or production
• Minimum 3 years of Quality Auditing experience
• Experienced in Procedural and Process developments
• Knowledge in: AS9100D (APU), PART-21 Subpart G (APU), Or AS9110C (ARU) Or PART-145 (ARU)

Other Information:

• Working location: Changi
• Working hours: Monday - Friday, 9am - 6pm
• Company transport provided at designated MRT stations

Job Description:

1. Supplier Quality Management

• Develop and implement supplier quality management programs.
• Conduct regular audits and assessments of supplier facilities to ensure compliance with quality standards and regulatory requirements.
• Evaluate and approve new suppliers based on quality performance and capability assessments.

2. Quality Assurance and Control

• Establish and maintain incoming material inspection processes and criteria.
• Monitor and report on supplier performance, including quality metrics, delivery performance, and corrective actions.
• Work with suppliers to develop and implement corrective action plans to address quality issues.

3. Continuous Improvement

• Identify opportunities for continuous improvement in supplier quality processes and systems.
• Lead initiatives to reduce defect rates and improve overall supplier performance.
• Collaborate with suppliers on process improvements and quality control enhancements.

4. Collaboration and Communication

• Serve as the primary point of contact for all supplier-related quality issues.
• Work closely with internal teams, including engineering, production, and procurement, to address quality concerns and improve supplier relationships.
• Facilitate effective communication and collaboration between suppliers and internal stakeholders.

5. Documentation and Compliance

• Ensure all supplier quality documentation is accurate, complete, and up-to-date.
• Maintain records of supplier audits, inspection results, and corrective actions.
• Ensure compliance with industry standards, customer requirements, and regulatory guidelines.

6. Training and Development

• Provide training and guidance to suppliers on quality standards, processes, and requirements.
• Mentor junior team members and support their professional development.

Job Requirements:

• Bachelor’s degree in Engineering, Quality Management, or a related field.
• Minimum of 7 years of experience in supplier quality engineering within the semiconductor manufacturing industry.
• Strong knowledge of semiconductor manufacturing processes and quality standards.
• Proven experience in conducting supplier audits and implementing corrective actions.
• Excellent problem-solving, analytical, and organizational skills.
• Strong communication and interpersonal skills, with the ability to work effectively with suppliers and internal teams.
• Preferred Skills: Certification in quality management (e.g., CQE, Six Sigma, Lean Manufacturing) is highly desirable.
• Proficiency in quality management tools and software.
• Experience with regulatory requirements and standards specific to the semiconductor industry.

Main Responsibilities:

The candidate will be responsible to support the QA Manager in establishing an independent quality system to monitor compliance with regulatory requirements.

Other tasks include:

• The receipt and control of all relevant regulatory and technical publication documents
• Revising and updating of Quality procedures and work instructions.
• Support all external audits by customers and certification bodies.
• Conduct internal and supplier audits.
• Conduct in-house quality-related trainings.
• Work with Supply Chain on new supplier evaluation and approval.
• Perform annual evaluation of existing suppliers with Supply Chain and update Approved Supplier List.
• Support Operations and Warehouse on customer claims investigation and other quality-related issues.
• Checking existing shelf life database and updating shelf life information in SAP for specific part numbers.
• Issuing of shelf life labels for items with expiry in warehouse.
• Reviewing and preparing of all Non-Conformance Reports (NCR) for closure.
• Preparation of quality / KPI related reports.
• Updating of NCR Master-list and E-filing of all warehouse NCR records in server.
• Updating of training register and personnel training records.
• Review and inspect aircraft cabin and avionics parts at warehouse when required.
• Assist in the company annual stock take if required
• Undertaking new improvement projects to improve process quality.
• Any ad-hoc tasks assigned by the QA Manager

Requirements:

• Degree / Diploma in Mechanical / Manufacturing / Aerospace Engineering with 3 to 6 years of relevant work experience, preferably in the Aviation industry.
• Knowledge of AS9100/9110/9120 standards and FAA/EASA/CAAS/CAAC part 145 requirements is highly preferred.
• Knowledge in the applications of MS Word, Excel, PowerPoint and Access will be advantageous.
• Should possess effective communication, interpersonal and problem solving skills

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.

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.

· Create quality inspection plans and work instructions for incoming, In-process or outgoing parts to ensure that components and products conform to specifications.

· Define training plan, train QC supervisors, QC technicians and QC inspectors to perform dimensional/functional inspection in accordance to work instructions.

· Perform First Article Inspection for newly inducted materials and parts.

· Perform qualification validation of equipment, processes and test methods

· Ensure the compliance of equipment and tools use during inspection in accordance to Calibration and Preventive Maintenance requirements.

· Participate in Process Failure Mode Effect and Analysis team to mitigate product risk arising from manufacturing

· Perform complaint handling, investigate root cause of complaint and perform Corrective Action and Preventive Action as necessary.

· Handle non-conformances and perform disposition of rejected parts, trend yield and rejects, investigate root cause of non-conformance and perform Corrective Action and Preventive Action as necessary.

· Maintain the manufacturing environment and perform gowning as necessary when working in controlled manufacturing environment e.g. clean room.

· Initiate and/or execute engineering changes in compliance with Engineering Change Control procedures

· Participate in external and internal audit to ensure company quality system is effective

· Participate in continuous improvement programs such as 6S program, yield improvement projects etc.

· Support new production introduction as a team member representing quality

· Perform other tasks as assigned by the supervisor

· Work experience as a quality engineer in a medical device manufacturing environment

(Candidates with Diploma in Engineering. Science or equivalent can be considered for Assistant Quality Engineer position. Candidates with more experience can be considered for Senior Quality Engineer position)

· Experience with qualification validation of equipment, processes and test methods for new product introduction

Duties and Responsibilities

Quality management and control

• Overall in charge of the entire packaging workshop, inclusive of data coding and laser printing and cellophane wrapping of final products.

• Manage the entire packing process, planning production schedule and communicate with cross-functional teams and departments to meet the delivery deadline

• Responsible for sampling and sample retention, inspection of incoming materials, approval of bulk, semi-finished products, finished products and packaging materials

• Maintain written and signed records of all audits and inspections as required and ensure the records are up-to-date and evaluated

• Review SOPs, protocols/batch records, reports, quality records (e.g. deviations, change controls, or CAPA) and ensure all the relevant testing are conducted and records are timely reviewed

• Implement and maintain quality procedures in compliance with regulations and internal policies, develop the quality procedures and reporting to management as required

• Participate in internal facilities inspection to evaluate and improvement of site quality system

• Responsible for maintenance of the factory premises, production equipment, and to ensure appropriate validations are timely performed and documented

• Ensure proper initial and regular training of operation personnel is being conducted and assist consultant for relevant training and awareness of basic regulatory.

• Investigate non-conformance and perform root cause analysis to deliver effective solutions via the corrective action and preventive action reporting process

• Responsible for compliance of workplace safety and assist to consultant relating to HSA and medical-licensing-related matters and to setup the operation system

Warehouse management and inventory control

• Oversee the warehousing and logistic operation, storage segregation, inventory accuracy and stock replenishment, planning quarterly & annually cycle count

• Ensure the implementation of standard procedures in warehouse and documentation

Ensure the warehouse facilities and equipment are well maintained

Knowledge/Skill Requirements:

• Excellent analytical skills with the ability to analyze data and identify trends.

• Strong communication skills, effective with team members and stakeholders at all levels.

• Attention to detail and ability to identify and resolve issues quickly and effectively.

• Strong problem-solving skills with the ability to think creatively and develop innovative solutions.

• Excellent organizational skills, capable of managing multiple tasks and priorities simultaneously.

• Extensive knowledge of quality control processes, procedures, and policies.

• Proficiency in Microsoft Office Suite and other relevant software applications.

• 8 - 10 years of experience in Quality Control within the steel industry or a manufacturing environment.

• Graduate degree or higher in pharmaceutical, chemical manufacturing or relevant field.

Expected High Performance Behaviors:

• Exhibit a positive attitude regarding work and responsibilities.

• Ability to work collaboratively within a team.

• Maintain effectiveness during significant changes in work tasks or environment, adjusting effectively to new work structures, processes, requirements, or cultures.

• Consistently seeking to enhance efficiency and improve quality standards.

Responsibilities:

• Perform internal audits as per internal audit schedule in accordance to AS9100, and PART-21 Subpart G requirements OR AS9110C and P-145 requirements
• Manage the qualification and authorization of Technician, Inspector and Signatory (APU)/ Certifying Staff (ARU)
• Facilitate training management, by doing operator audits, manage operator certifications, stamp register control, product authorization matrix, and follow up of re-certification
• Support external audits, (Civil Aviation Authorities, customers and Certification bodies)
• Facilitate and participate in Analysis and Decision committee / Material Review board, related to product non conformity. (APU)
• Manage and update Quality procedures in the Quality Management System
• Validate the qualification of new test equipment
• Participate and contribute in Production Readiness Reviews
• Perform training on Quality related topics for staff
• Manage the internal production or repair quarantine.

Requirements:

• Degree/ Diploma in Quality, Quality Management or Mechanical Engineering or Electrical Engineering or Electronic Engineering or Equivalent
• Minimum 3 years of experience in Avionics Workshop Maintenance Environment/ Electronics Workshop / Mechanical Workshop or production
• Minimum 3 years of Quality Auditing experience
• Experienced in Procedural and Process developments
• Knowledge in: AS9100D (APU), PART-21 Subpart G (APU), Or AS9110C (ARU) Or PART-145 (ARU)

Other Information:

• Working location: Changi
• Working hours: Monday - Friday, 9am - 6pm
• Company transport provided at designated MRT stations

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.