Post Market Surveillance (PMS) Engineer

Cyient; Hyderabad; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Cyient is seeking a quality professional with 5+ years of Medical Device Quality experience, including complaint handling, PMS, and risk management, to strengthen post-market vigilance.

You will review and update complaint records and investigations, establish traceability between complaints, CAPAs, RM Files, FMEAs, Design Controls and Verification/Validation evidence, support risk assessments, audits, regulatory inspections, and cross‑functional product improvements.

Qualifications

• Minimum 5+ years in Medical Device Quality, Complaint Handling, PMS, or Risk Management.
• Review and update complaint records, investigation reports, and PMS documentation.
• Collaborate with Quality, Regulatory, R&D, Manufacturing and Clinical teams to drive product improvements.

Responsibilities

• Conduct complaint investigations and assess reportability for vigilance reporting.
• Analyze complaint trends, PMS data, and customer feedback to identify signals.
• Review and maintain CAPA records and ensure timely closure.
• Support internal audits, regulatory inspections, and management reviews.

Skills

Medical device quality

Complaint handling

PMS

Risk management

Tools

CAPA process

FMEA

Design Controls

Vigilance reporting

Job description

Job Description

5+ years of experience in Medical Device Quality, Complaint Handling, PMS, or Risk Management.

Review and update complaint records, investigation reports, complaint classifications, and PMS documentation. Conduct complaint investigations and assess reportability for vigilance/adverse event reporting. Analyze complaint trends, PMS data, and customer feedback to identify product quality and safety signals. Review and maintain CAPA records, ensuring effectiveness and timely closure. Establish and maintain traceability between complaints, PMS findings, CAPAs, Risk Management Files, FMEAs, Design Controls, and Verification/Validation evidence. Support risk assessments and recommend updates to risk management documentation based on post-market findings. Collaborate with Quality, Regulatory, R&D, Manufacturing, and Clinical teams to drive product improvements. Support internal audits, regulatory inspections, and management reviews.