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

Roles and Responsibilities
Risk management and design control activities for Class I & II medical devices, ensuring compliance with ISO 14971, ISO 13485, FDA QMSR, EU MDR, and related regulatory requirements. Responsible for developing and maintaining Risk Management Files, FMEAs, hazard analyses, design control documentation, and traceability artifacts throughout the product lifecycle.