Job Description
QMS Compliance Engineer
Kamunting, Malaysia | Posted on 06/17/2026
Responsibilities
- Establish, implement, maintain, and continuously improve the Quality Management System (QMS) in compliance with:
- ISO 13485
- ISO 14971
- FDA 21 CFR Part 820 / QMSR
- MDSAP requirements
- EU MDR requirements (where applicable)
- Customer-specific requirements
- Ensure all quality procedures, work instructions, forms, and records are maintained and controlled in accordance with document control requirements.
- Monitor QMS effectiveness through KPI tracking, quality performance metrics, trend analysis, and management reporting.
- Coordinate and facilitate Management Review Meetings, including preparation of inputs, reports, and follow‑up actions.
2. Internal and External Audits
- Develop and execute the annual internal audit program, including planning, ...