Post Market Surveillance (PMS) Engineer

Job description

5+ years of experience in Medical Device Quality, Complaint Handling, PMS, or Risk Management. Review and update complaint records, investigation reports, complaint classifications, and PMS documentation. Conduct complaint investigations and assess reportability for vigilance/adverse event reporting. Analyze complaint trends, PMS data, and customer feedback to identify product quality and safety signals. Review and maintain CAPA records, ensuring effectiveness and timely closure. Establish and maintain traceability between complaints, PMS findings, CAPAs, Risk Management Files, FMEAs, Design Controls, and Verification/Validation evidence. Support risk assessments and recommend updates to risk management documentation based on post-market findings. Collaborate with Quality, Regulatory, R&D, Manufacturing, and Clinical teams to drive product improvements. Support internal audits, regulatory inspections, and management reviews. Roles and Responsibilities Review and update applicable complaint records, investigation records, complaint classifications, vigilance activities, trending information, PMS data, and CAPA records. Establish appropriate linkage with risks, FMEAs, design controls, and verification evidence.