Quality Engineer-QMS
Quality Engineer-QMS
Posted on :
07-06-2025
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1 Vacancy
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Job Description
Job Description:
- As a Quality Engineer II you will be a key contributor to the implementation maintenance and continuous improvement of the Quality Management System (QMS).
- You will collaborate cross-functionally to ensure compliance with regulatory requirements drive root cause investigations and support quality initiatives that enhance product and process performance.
- Your role will be instrumental in ensuring that quality standards are embedded across the product lifecycle and that QMS processes are effectively executed and continuously improved.
- Ensure compliance with internal QMS procedures and external regulatory requirements (e.g. ISO 13485 FDA 21 CFR Part 820).
- Lead and support Nonconformance (NC) and Corrective and Preventive Action (CAPA) processes ensuring timely closure and effectiveness verification.
- Collaborate with manufacturing engineering and supply chain teams to drive process improvements and reduce quality risks.
- Participate in internal audits and support external audits/inspections by regulatory bodies and notified bodies.
- Monitor and analyse quality metrics (KPIs) identify trends and implement data-driven improvements.
- Support change control processes ensuring quality impact assessments are conducted and documented.
- Manage complaint investigations and contribute to field action assessments and execution.
- Apply risk management principles (ISO 14971) throughout product and process development.
- Support validation activities (IQ/OQ/PQ) for equipment processes and software.
- Optimize inspection and sampling strategies using statistical techniques (e.g. SPC DOE Gage R&R).
- Promote Human Factors Engineering principles in product and process design.
- Contribute to training and awareness programs to reinforce QMS compliance and quality culture.
- Proven experience in quality engineering within a regulated industry (medical device preferred).
- Strong knowledge of QMS standards and regulations (ISO 13485 FDA QSR EU MDR).
- Proficiency in quality tools and methodologies: CAPA FMEA Root Cause Analysis 8D 5 Whys.
- Experience with document control change management and validation protocols.
- Familiarity with complaint handling risk management and audit readiness.
- Strong analytical communication and project management skills.
- Ability to work independently and collaboratively in cross-functional teams.
- Experience interacting with regulatory agencies (e.g. FDA TUV MoH).
- Working knowledge of electronic QMS platforms (e.g. Master Control Track Wise).
- Certification in quality (e.g. CQE CQA Six Sigma) is a plus.
- Strong computer literacy and data analysis.
Employment Type
Full Time
Key Skills
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