RISK Quality Engineer

Cyient; Hyderabad; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Cyient in Hyderabad, India is seeking a senior professional with 5+ years of experience in Medical Device Quality, Risk Management, Design Assurance, or Product Development.

You will develop and maintain Risk Management Files, perform risk assessments, ensure end-to-end traceability between requirements, risks, controls, verification, and post-market feedback using Codebeamer and Windchill, and support audits and regulatory reviews. Act as RM SME during audits.

Qualifications

• 5+ years of experience in Medical Device Quality, Risk Management, Design Assurance, or Product Development.

Responsibilities

• Develop, review, and maintain Risk Management Files, DFMEA, PFMEA, UFMEA, Hazard Analysis, and V&V documentation.
• Perform risk assessments for complaints, CAPAs, engineering changes, supplier quality issues, and post-market activities.
• Ensure traceability between requirements, risks, controls, verification, validation, and post-market feedback using Codebeamer and Windchill.
• Collaborate with Quality, Regulatory Affairs, R&D, Manufacturing, Supplier Quality, and Medical Safety.
• Act as Risk Management SME during audits, inspections, and regulatory reviews.

Skills

Medical Device Quality

Risk Management

Design Assurance

Product Development

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.