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, ...