QMS Compliance Engineer

Job Responsibilities: 1. Quality Management System (QMS) Establish, implement, maintain, and continuously improve the Quality Management System (QMS) in compliance with: o ISO 13485 o ISO 14971 o FDA 21 CFR Part 820 / QMSR o MDSAP requirements o EU MDR requirements (where applicable) o 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, scheduling, conducting, and reporting audit activities. Prepare audit plans, checklists, reports, and corrective action follow-up documentation. Verify the implementation and effect...