Risk Quality Engineer (Medical Devices Class I & II)

Cyient; Hyderabad; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Cyient is seeking a senior Risk Management professional for Medical Devices to lead risk analyses, maintain RMF and design controls, and ensure regulatory compliance across ISO 14971, ISO 13485, FDA QMSR, and EU MDR. You will partner with Quality, Regulatory, R&D, and Manufacturing teams.

Ideal candidate will drive end-to-end traceability, support post-market activities, and serve as SME during regulatory reviews and inspections.

Qualifications

• Lead risk management and design controls for Class I/II medical devices.

Responsibilities

• Perform risk assessments for complaints, CAPAs, engineering changes, supplier quality issues, and post-market activities.
• Maintain end-to-end traceability between requirements, risks, controls, verification, and validation.
• Collaborate with Quality, Regulatory, R&D, Manufacturing, Supplier Quality, and Medical Safety.
• Act as Risk Management SME during audits, inspections, and regulatory reviews.

Skills

ISO 14971

DFMEA

PFMEA

UFMEA

Hazard Analysis

Health Hazard Analysis

RMF Development

Design Controls

DHF Management

Requirements Traceability

Change Management

Verification & Validation

CAPA & Post-Market Risk

Regulatory Compliance

Codebeamer & Windchill

Audit Readiness

Regulatory Inspection Support

Cross-Functional Stakeholder Mgmt

Technical Writing

Analytical & Problem-Solving

Tools

Codebeamer

Windchill

Job description

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 Technical 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.