RISK Quality Engineer

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.