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

📌 Risk Quality Engineer (Medical Devices Class I & II) (Hyderabad)
🏢 Cyient
📍 Hyderabad