Total 939 quality manager job vacancies in Quality Assurance / Control category

Job Description

Quality Management Systems / Quality Assurance Manager

Department:  Quality,Regulatory & Compliance
Location: Singapore
Reports to: Business Director
Employment Type:  Full-time, Permanent
Job Level: Manager / Senior Manager

About AITbiotech

AITbiotech Pte Ltd is aSingapore-based molecular diagnostics and bioinformatics company dedicated to advancing clinical decision-making through innovative genomic and diagnostic technologies. Our product portfolio — including abONE, abSEQ, abNEX, abGenix X,and abTES — serves clinicians and healthcare institutions across SoutheastAsia. We are committed to the highest standards of quality, safety, and regulatory compliance as we scale our operations and expand into new markets.

Role Overview

The QMS/QA Manager will be responsible for maintaining and continuously improving AITbiotech's Quality Management System in alignment with ISO 13485, HSA (Singapore MDA) regulations, and CE-IVD/IVDR requirements. This is a dual-focus role: ensuring our QMS operates robustly across all product lines while actively leveraging AI-assisted tools to modernise quality processes, documentation workflows, and regulatory intelligence. The successful candidate will be a pragmatic quality professional who understands both the regulatory landscape for in vitro diagnostics and the emerging potential of AI to enhance quality operations.

Key Responsibilities

1.  QMS Maintenance & Continuous Improvement

• Own and manage the end-to-end ISO 13485-certified QMS, including document control, change control, CAPA, internal audits, and management review processes.
• Conduct periodic QMS gap analyses, identify process weaknesses, and drive corrective and preventive action plans.
• Maintain and improve the Quality Manual, SOPs, work instructions, and related controlled documents across all departments.
• Lead internal audits and coordinate external/third-party audits; prepare audit responses and oversee closure of non-conformances.
• Foster a quality culture across the organization through training programmes and quality awareness initiatives.

2.  Regulatory Affairs & Certifications

• Manage and maintain regulatory submissions and product registrations with HSA (Singapore MDA) for IVD medical devices.
• Lead CE-IVD/IVDR compliance activities, including technical documentation, Declaration of Conformity, and liaison with Notified Bodies.
• Monitor changes to applicable regulations (ISO 13485, IVDR, HSA MDA, ASEAN AMDD) and assess impact on existing QMS and product registrations.
• Coordinate with external regulatory consultants and legal counsel on cross-border market access strategies in Southeast Asia and beyond.
• Support product development teams with regulatory input during design and development, risk management (ISO14971), and design verification/validation activities.
• Manage post-market surveillance activities including complaint handling, vigilance reporting, and periodic safety update reports.

3.  AI Integration in Quality Operations

• Identify and pilotAI-assisted tools for QMS functions including intelligent document management, automated non-conformance tracking, audit trail analysis, and regulatory intelligence monitoring.
• Collaborate with IT and bioinformatics teams to evaluate and deploy AI/ML solutions that improve quality data analysis, risk assessment, and complaint trending.
• Develop validation frameworks and procedures for AI tools used in quality-critical processes, ensuring compliance with applicable standards.
• Stay current with industry guidance on AI use in regulated medical device environments (e.g., FDA AI/ML guidance, IMDRF frameworks) and translate into internal policies.
• Champion responsible AI adoption within the quality function — balancing efficiency gains with regulatory traceability and auditability requirements.

4.  Supplier & Partner Quality

• Qualify and periodically audit critical suppliers and contract manufacturers; manage approved supplier lists.
• Review and negotiate Quality Agreements with suppliers, distributors, and contract service providers.
• Manage OEM partner quality interfaces, ensuring incoming product quality and supply chain compliance.

5.  Cross-functional Collaboration

• Partner with R&D, operations, sales, and commercial teams to embed quality requirements into new product introduction and product lifecycle management.
• Provide QA sign-off for batch releases, labelling reviews, and product changes.
• Represent the quality function at senior leadership level; produce quality KPI dashboards and trend reports.

Qualifications & Experience

Essential

• Bachelor's degree or higherin Life Sciences, Biomedical Engineering, Molecular Biology, or a relateddiscipline.
• Minimum 5 years of experiencein Quality Assurance/QMS roles within a regulated medical device or IVDenvironment.
• Demonstrated working knowledge of ISO 13485:2016 and hands-on experience maintaining or auditing a certified QMS.
• Practical experience with HSA (Singapore MDA) IVD product registration processes.
• Solid understanding of CE-IVD/IVDR requirements, technical file structure, and conformity assessment pathways.
• Proficiency in CAPA management, risk management (ISO 14971), and non-conformance investigation methodologies.
• Strong documentation skills with meticulous attention to detail.
• Excellent communicator with the ability to engage regulators, auditors, and internal stakeholders at all levels.

Preferred

• Postgraduate qualification in Regulatory Affairs, Quality Management, or equivalent.
• Certified Quality Auditor(CQA, IRCA, or equivalent) or ISO 13485 Lead Auditor certification.
• Experience in next-generationsequencing (NGS), molecular diagnostics, or genomics-based IVDs.
• Exposure to ASEAN regulatory frameworks (e.g., BFAD Philippines, NPRA Malaysia, TFDA Taiwan).
• Hands-on experience with AI/automation tools applied to quality or regulatory processes (e.g., AI-driven document review, intelligent CAPA platforms, regulatory intelligence software).
• Familiarity with electronic QMS (eQMS) platforms such as Veeva Vault QMS, Master Control, or Qualio.
• Experience in startup or scale-up environment with the ability to operate independently and build processes from limited infrastructure.

Core Competencies

• Regulatory Acumen — deep understanding of IVD regulatory frameworks and ability to translate requirements into actionable QMS controls.
• Analytical Thinking —data-driven approach to quality problem solving, root cause analysis, and trend identification.
• AI Curiosity &Adaptability — genuine interest in applying AI/ML tools to regulated quality environments, with a compliance-first mindset.
• Cross-functional Influence —ability to influence without authority across R&D, operations, and commercial teams.
• Ownership & Initiative —self-directed and proactive; comfortable operating in a fast-moving scale-up environment.
• Audit Readiness — confident representing the company during regulatory inspections and stakeholder briefings.

Company's Profile
Julian Grey's client is an established engineering firm with strong regional presence, known for delivering high-profile projects and advanced technical consulting expertise.

Responsibilities

• Review quality plans, inspection and test plans, and project quality procedures.
• Improve operational processes affecting project quality.
• Coordinate with suppliers, vendors, and internal teams on quality matters.
• Review welding procedures, qualifications, and technical documents.
• Conduct staged inspections for fabrication and installation works.
• Witness non-destructive testing activities, including Ultrasonic testing and magnetic particle testing.
• Ensure compliance with quality, safety, and health requirements.
• Lead QA/QC staff and maintain required quality records.

Requirements

• Diploma or Degree in Mechanical Engineering or equivalent.
• Certified Welding Inspector qualification, such as CWI, AWS QC-1, or CSWIP 3.1.
• Minimum 5 years of QA/QC experience, preferably in fabrication, construction, or engineering projects.

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Interested Applicants
Please WA Victoria @ 8887 7742
Shortlisted candidates will be notified

Victoria Siew
Reg No. R25158665
Julian Grey Corporate Advisory Pte. Ltd.
EA License No: 19C9568 

Your Role

The incumbent is accountable for the Process Control section of Quality Department within EWS organization. 

Main responsibility is to ensure the wafers in EWS are processed efficiently without any Quality issue.

• To ensure all changes within EWS is managed systematically according to the SOP262
• To schedule and chair all the PCRBs for EWS
• To ensure EWS Change management is done effectively and efficiently
• To schedule and chair all the FMEA review in EWS
• To ensure all the risks identified in FMEA are assessed and preventive and detection control are put in place
• To ensure all process control in EWS have been set up and are reviewed and updated regularly
• To look out consistently for any process area that can be improved to reduce Quality risk
• To schedule and chair MRB for CMOSF9 visual SBL

YOUR SKILLS & EXPERIENCES

• Bachelor degree in sciences or similar 
• 3 years of experience in the field particularly in Semiconductor manufacturing business 
• Extensive knowledge of excel, office suite
• English business proficiency

Job Description:

• Work as a team to create and implement comprehensive quality assurance plans that outline the processes and procedures for ensuring quality throughout the product lifecycle, from design to manufacturing to delivery.
• Conduct internal and external audits to assess the effectiveness of quality control procedures and identify areas for improvement.
• When quality issues are identified, work to determine the root cause of the problem, develop corrective actions, and monitor their implementation to ensure they are effective.
• Ensure that company's products and services meet relevant industry standards and regulations, including standards like NADCAP.
• Provide training and awareness programs for employees on quality control procedures and best practices.
• Actively participate in continuous improvement projects to enhance quality and reduce costs.
• Collaborate with suppliers to ensure that their products and services meet the required quality standards.

Requirement:

• Min Degree in Engineering
• Min 3 years of experience in certifying staff and lead QA activities

To submit your application, please apply online apply@rn-care.com or call +(65) 6513 5697 for private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd
EA License No: 17C8900

SUMMARY

We are looking for an experienced Operations Quality Project Manager to join our team. In this role, you will lead and drive medium to large-scale testing cycles, with direct impact on large-scale e-commerce platforms. You will work closely with cross-functional partners to ensure high-quality delivery across end-to-end customer journeys, while continuously improving testing processes and strategies.

DESCRIPTION

• Develop deep subject matter expertise across end-to-end (E2E) customer journeys, business processes, and supporting systems
• Partner with business and technical teams to understand solutions, and define comprehensive test strategies across use cases
• Lead functional tracks within a centralized testing function
• Manage, plan, and organise activities across validation planning and execution phases
• Collaborate with multiple testing partner teams to ensure seamless execution
• Drive alignment across teams to deliver successful testing outcomes
• Lead test resources and ensure effective execution of deliverables
• Provide inputs to enhance testing processes and drive continuous improvement

KEY REQUIREMENTS

• 7+ years of professional experience in a Quality role leading projects and initiatives
• Strong UAT, QC, or Quality experience within e-commerce, mobile, or retail organizations
• Strong technical, analytical, and problem-solving skills
• Proven experience leading cross-functional teams and building stakeholder relationships
• Experience working with globally distributed teams

PREFERRED SKILLS

• 5+ years of experience working with complex, integrated systems
• Experience with AI-driven quality validation techniques and automation
• Ability to identify risks proactively and drive resolutions
• Strong facilitation, negotiation, and conflict resolution skills
• Passion for innovation and continuous improvement

EDUCATION & CERTIFICATIONS

• Bachelor’s degree or equivalent, preferably in a technical field
• PMP or Project Management certification is a plus
• Relevant quality certifications such as ISTQB are advantageous

We regret to inform that only shortlisted candidates will be notified.

EA Registration No.: Melvin Chua Han Wei, R24123531

Allegis Group Singapore Pte Ltd, Company Reg No. 200909448N, EA Licence No. 10C4544

Responsibilities:

• Maintain accurate and up-to-date ISO 9001, ISO 14001, and ISO 13485 documentation, including Quality Manuals, procedures, work instructions, and records, to ensure system compliance and management review readiness.
• Plan, coordinate, and conduct internal and external audits to ensure organizational readiness for third-party certification, management reviews, and customer audits.
• Collaborate with internal stakeholders to support and participate in customer and supplier audits to ensure compliance requirements are met.
• Review audit findings, develop corrective action plans, and drive continuous improvement initiatives.
• Generate and review supplier quality performance reports, work closely with suppliers to resolve non-conformances, and promote continuous improvement.
• Issue, monitor, and follow up on Supplier Corrective Action Requests (SCAR), ensuring effectiveness and timely closure.
• Support qualification and onboarding of new suppliers to maintain a robust pipeline aligned with production requirements.
• Manage calibration schedules and preventive maintenance programs for equipment to ensure operational reliability and compliance.
• Address quality issues arising from production and customer feedback by working closely with production teams to implement corrective actions and resolve customer complaints with proper documentation.
• Ensure timely closure of Corrective and Preventive Actions (CAPA), non-conformance reports, and customer complaints, and publish quality performance reports.
• Lead Material Review Board (MRB) meetings with cross-functional teams to perform root cause analysis, implement corrective actions, and verify effectiveness.
• Supervise and lead QC inspectors to ensure parts inspection compliance with engineering drawings and quality standards.

Qualifications:

• Diploma in Quality Management, Engineering, Manufacturing, or a related field.
• Min 3 years of relevant experience in quality or manufacturing environments, with exposure to audits and documentation.
• Basic understanding of supplier management and quality coordination.
• Familiarity with commonly used quality management standards (e.g. ISO systems).
• Working knowledge of quality tools and process control methods.

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

Wecruit Pte Ltd

EA License No: 20C0270

EA Personnel: Nyon Hock Sen (Aden)

EA Personnel Reg No: R24124070

Responsibilities:

• Maintain accurate and up-to-date ISO 9001, ISO 14001, and ISO 13485 documentation, including Quality Manuals, procedures, work instructions, and records, to ensure system compliance and management review readiness.
• Plan, coordinate, and conduct internal and external audits to ensure organizational readiness for third-party certification, management reviews, and customer audits.
• Collaborate with internal stakeholders to support and participate in customer and supplier audits to ensure compliance requirements are met.
• Review audit findings, develop corrective action plans, and drive continuous improvement initiatives.
• Generate and review supplier quality performance reports, work closely with suppliers to resolve non-conformances, and promote continuous improvement.
• Issue, monitor, and follow up on Supplier Corrective Action Requests (SCAR), ensuring effectiveness and timely closure.
• Support qualification and onboarding of new suppliers to maintain a robust pipeline aligned with production requirements.
• Manage calibration schedules and preventive maintenance programs for equipment to ensure operational reliability and compliance.
• Address quality issues arising from production and customer feedback by working closely with production teams to implement corrective actions and resolve customer complaints with proper documentation.
• Ensure timely closure of Corrective and Preventive Actions (CAPA), non-conformance reports, and customer complaints, and publish quality performance reports.
• Lead Material Review Board (MRB) meetings with cross-functional teams to perform root cause analysis, implement corrective actions, and verify effectiveness.
• Supervise and lead QC inspectors to ensure parts inspection compliance with engineering drawings and quality standards.

Qualifications:

• Diploma in Quality Management, Engineering, Manufacturing, or a related field.
• Min 3 years of relevant experience in quality or manufacturing environments, with exposure to audits and documentation.
• Basic understanding of supplier management and quality coordination.
• Familiarity with commonly used quality management standards (e.g. ISO systems).
• Working knowledge of quality tools and process control methods.

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

Wecruit Pte Ltd

EA License No: 20C0270

EA Personnel: Nyon Hock Sen (Aden)

EA Personnel Reg No: R24124070

Job Description

• Maintain and improve Quality, Food Safety and Halal Management Systems.
• Ensure compliance with ISO 22000, ISO 9001, HACCP, GMP and regulatory requirements.
• Conduct internal audits, GMP inspections and food safety assessments.
• Coordinate external audits, certification activities and regulatory inspections.
• Manage Singapore and Indonesia Halal certification requirements.
• Act as a Qualified Person (QP) for export certification and ensure compliance with importing country requirements.
• Maintain quality system documentation and ensure audit readiness.
• Conduct training on quality, food safety, hygiene and Halal requirements.
• Monitor quality system performance and drive continuous improvement initiatives.
• Liaise with regulatory authorities, certification bodies and internal departments on quality and food safety matters.

Requirements:

• Bachelor's degree in Food Science or an equivalent field.
• Strong knowledge of ISO 22000, ISO 9001, HACCP, GMP, and food safety regulations.
• Good understanding of Halal requirements, export certification, and regulatory compliance.
• Good auditing, documentation and organisation skills.
• Strong communication and interpersonal skills.
• Proficient in Microsoft Office applications.

AssistantManager, Quality Assurance & Quality Control

Job Description & Requirements

Responsibilities:

- Ensure the implementation and maintenance of allquality and food safety control processes are being complied to company’sstandard, HACCP, ISO and local statutory requirement.

- To conduct in house food safety training toproduction/operation staffs.

- To manage customer complaints investigation andperform troubleshooting and drive processimprovement program to ensure high standard of food safety and quality.

- Provide technical advice to support anotherdepartment as and when necessary

- Monitoring product integrity and conduct producttesting for new and regular products.

- To support Production Manager for admin work.

- Manage external inspection and liaise withregulatory agencies

- To kick start sustainability initiatives for the company putting in process andcertification.

- Train junior QA to perform her role as QA executive.

- Perform ad-hoc duties as assigned by management

Job Description:

• Work as a team to create and implement comprehensive quality assurance plans that outline the processes and procedures for ensuring quality throughout the product lifecycle, from design to manufacturing to delivery.
• Conduct internal and external audits to assess the effectiveness of quality control procedures and identify areas for improvement.
• When quality issues are identified, work to determine the root cause of the problem, develop corrective actions, and monitor their implementation to ensure they are effective.
• Ensure that company's products and services meet relevant industry standards and regulations, including standards like NADCAP.
• Provide training and awareness programs for employees on quality control procedures and best practices.
• Actively participate in continuous improvement projects to enhance quality and reduce costs.
• Collaborate with suppliers to ensure that their products and services meet the required quality standards.

Requirement:

• Min Degree in Engineering
• Min 3 years of experience in certifying staff and lead QA activities

To submit your application, please apply online apply@rn-care.com or call +(65) 6513 5697 for private and confidential discussion.

Your interest will be treated with the strictest of confidence. We regret that only shortlisted candidates will be notified or contacted.

RN Care Pte. Ltd
EA License No: 17C8900

Responsibilities:

• Maintain accurate and up-to-date ISO 9001, ISO 14001, and ISO 13485 documentation, including Quality Manuals, procedures, work instructions, and records, to ensure system compliance and management review readiness.
• Plan, coordinate, and conduct internal and external audits to ensure organizational readiness for third-party certification, management reviews, and customer audits.
• Collaborate with internal stakeholders to support and participate in customer and supplier audits to ensure compliance requirements are met.
• Review audit findings, develop corrective action plans, and drive continuous improvement initiatives.
• Generate and review supplier quality performance reports, work closely with suppliers to resolve non-conformances, and promote continuous improvement.
• Issue, monitor, and follow up on Supplier Corrective Action Requests (SCAR), ensuring effectiveness and timely closure.
• Support qualification and onboarding of new suppliers to maintain a robust pipeline aligned with production requirements.
• Manage calibration schedules and preventive maintenance programs for equipment to ensure operational reliability and compliance.
• Address quality issues arising from production and customer feedback by working closely with production teams to implement corrective actions and resolve customer complaints with proper documentation.
• Ensure timely closure of Corrective and Preventive Actions (CAPA), non-conformance reports, and customer complaints, and publish quality performance reports.
• Lead Material Review Board (MRB) meetings with cross-functional teams to perform root cause analysis, implement corrective actions, and verify effectiveness.
• Supervise and lead QC inspectors to ensure parts inspection compliance with engineering drawings and quality standards.

Qualifications:

• Diploma in Quality Management, Engineering, Manufacturing, or a related field.
• Min 3 years of relevant experience in quality or manufacturing environments, with exposure to audits and documentation.
• Basic understanding of supplier management and quality coordination.
• Familiarity with commonly used quality management standards (e.g. ISO systems).
• Working knowledge of quality tools and process control methods.

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

Wecruit Pte Ltd

EA License No: 20C0270

EA Personnel: Nyon Hock Sen (Aden)

EA Personnel Reg No: R24124070

Responsibilities:

• Maintain accurate and up-to-date ISO 9001, ISO 14001, and ISO 13485 documentation, including Quality Manuals, procedures, work instructions, and records, to ensure system compliance and management review readiness.
• Plan, coordinate, and conduct internal and external audits to ensure organizational readiness for third-party certification, management reviews, and customer audits.
• Collaborate with internal stakeholders to support and participate in customer and supplier audits to ensure compliance requirements are met.
• Review audit findings, develop corrective action plans, and drive continuous improvement initiatives.
• Generate and review supplier quality performance reports, work closely with suppliers to resolve non-conformances, and promote continuous improvement.
• Issue, monitor, and follow up on Supplier Corrective Action Requests (SCAR), ensuring effectiveness and timely closure.
• Support qualification and onboarding of new suppliers to maintain a robust pipeline aligned with production requirements.
• Manage calibration schedules and preventive maintenance programs for equipment to ensure operational reliability and compliance.
• Address quality issues arising from production and customer feedback by working closely with production teams to implement corrective actions and resolve customer complaints with proper documentation.
• Ensure timely closure of Corrective and Preventive Actions (CAPA), non-conformance reports, and customer complaints, and publish quality performance reports.
• Lead Material Review Board (MRB) meetings with cross-functional teams to perform root cause analysis, implement corrective actions, and verify effectiveness.
• Supervise and lead QC inspectors to ensure parts inspection compliance with engineering drawings and quality standards.

Qualifications:

• Diploma in Quality Management, Engineering, Manufacturing, or a related field.
• Min 3 years of relevant experience in quality or manufacturing environments, with exposure to audits and documentation.
• Basic understanding of supplier management and quality coordination.
• Familiarity with commonly used quality management standards (e.g. ISO systems).
• Working knowledge of quality tools and process control methods.

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

Wecruit Pte Ltd

EA License No: 20C0270

EA Personnel: Nyon Hock Sen (Aden)

EA Personnel Reg No: R24124070

Job Description

• Responsible for engaging customers flagged by the anti-fraud system and managing end-to-end case handling.
• Leverage data insights to support the development and enhancement of anti-fraud business rules in compliance with regulatory requirements.
• Conduct quality assurance checks on FAA-related documentation to ensure accuracy, completeness, and regulatory compliance.
• Manage customer complaints with professionalism, ensuring timely investigation and resolution.
• Work closely with cross-functional teams to investigate, escalate, and follow up on anti-fraud cases.
• Prepare relevant business data and submission materials.
• Support additional duties and projects as assigned.

Job Requirement

• Bachelor’s degree or above with at least 1 year of relevant experience in wealth banking, anti-scam/fraud prevention, or customer service operations.
• Good understanding of wealth management products, banking operations, and FAA/MAS regulatory guidelines
• Strong communication skills in English and Mandarin, able to engage confidently with Mandarin-speaking customers
• Comfortable handling challenging conversations and sensitive customer situations
• Strong attention to detail with a high level of accuracy in document review and compliance checks
• Analytical mindset with curiosity to identify patterns, risks, and anomalies
• Proficient in Microsoft Excel and able to manage multiple priorities in a fast-paced environment

• People-centered Organisational Culture
• Teamwork
• Innovative and Energetic Workplace with a Growth Mindset

JOB DESCRIPTION

We are looking for a full-time deputy manager who is disciplined and meticulous on critical matters, so that records are relevant, accurate and properly kept. In addition, the candidate should have a systems improvement and a forward looking mindset. By focusing on the bigger picture, the deputy manager builds trust in the organisation across departments so process improvements are welcomed and implemented.

Prior experience in student records management, student admissions, and internal audit will be a strong advantage. Working in EduTrust schools is not necessary but will be a plus.

Responsibilities (Registrar) include:

1. Check and process student admissions and student contracts
2. Maintain accurate student records and database
3. Administer student pass-related matters

Responsibilities (Quality Assurance) include:

1. Oversee the record keeping by department heads related to critical documents
2. Assist the Principal to organise regular departmental reviews related to compliance and continual improvement
3. Assist the Principal to identify systematic issues and streamline work processes across the organisation as part of continual improvement
4. Oversee feedback management and complaints. Administer surveys

Other Supporting Responsibilities (Programme Operations) include:

1. Provide operations support to the running of classes
2. Coordinate student services and career and industry-related events

Requirements

• Possess at least a Degree or equivalent
• At least 5 Years of working experience in the related fields
• Attributes: Disciplined, meticulous, big picture, problem solver, high ethical integrity
• Required skills: Spreadsheets and formulas, data analysis, critical thinking, writing clearly and concisely

Quality Manager

We are seeking a Quality Manager to lead the company's Quality Management System (QMS) and ensure products, processes, and operations consistently meet customer, regulatory, and internal quality requirements. The role will oversee quality assurance and quality control activities, drive continuous improvement initiatives, and support customer and certification audits.

Key Responsibilities

• Manage and maintain the company's Quality Management System in accordance with ISO 9001 and ISO 13485 requirements.

• Lead the QA team and oversee incoming, in-process, and outgoing quality activities.

• Ensure products meet customer specifications, drawings, and quality standards.

• Investigate quality issues and drive effective corrective and preventive actions.

• Handle customer complaints, quality concerns, and audit requirements.

• Plan and conduct internal audits, management reviews, and continuous improvement initiatives.

• Work closely with Production, Engineering, and Project teams to improve process capability and product quality.

• Monitor quality performance metrics and implement actions to reduce defects and customer complaints.

• Manage calibration systems and ensure compliance of measuring equipment.

• Support supplier quality management and new product introduction activities.

Key Skills & Requirements

• Strong knowledge of ISO 9001 and ISO 13485 Quality Management Systems.

• Experience in quality management within a manufacturing environment, preferably plastic injection molding.

• Familiarity with quality tools such as 8D, FMEA, Root cause analysis etc.

• Strong leadership, communication, and problem-solving skills.

• Experience managing customer audits, certification audits, and quality documentation.