Risk Quality Engineer (Medical Devices Class I & II)

Role and Responsibilities:
5+ years of experience in Medical Device Quality, Risk Management, Design Assurance, or Product Development.Develop, review, and maintain Risk Management Files, DFMEA, PFMEA, UFMEA, Hazard Analysis, HHA, DHF, and V&V documentation.
Perform risk assessments for complaints, CAPAs, engineering changes, supplier quality issues, manufacturing nonconformances, and post-market activities.
Ensure end-to-end traceability between requirements, risks, controls, verification, validation, complaints, and post-market feedback using Codebeamer and Windchill.
Collaborate with cross-functional teams including Quality, Regulatory Affairs, R&D, Manufacturing, Supplier Quality, and Medical Safety. Support field actions, corrections & removals, product safety evaluations, and management review boards.
Act as Risk Management SME during audits, inspections, and regulatory reviews.
Skills:
ISO 14971 Risk Management
DFMEA, PFMEA, UFMEA & Hazard Analysis
Health Hazard Analysis (HHA)
Risk Management File (RMF) Development
Design Controls & DHF Management
Requirements Traceability & Change Management
Verification & Validation (V&V)
Complaint Handling, CAPA & Post-Market Risk Assessment
Product Safety & Field Corrective Action Evaluation
Regulatory Compliance (ISO 13485, FDA QMSR, EU MDR)
Codebeamer & Windchill
Audit Readiness & Regulatory Inspection Support
Cross-Functional Stakeholder Management T
echnical Writing, Analytical & Problem-Solving Skills

Work arrangement
No