PMS & Medical Device Quality Engineer

Location: Hyderabad, Telangana, IndiaExperience: 5-7 YearsEmployment Type: Contract – Performance BasedIndustry: Medical Devices
About the Role
HELION is looking for an experienced Post-Market Surveillance (PMS) & Medical Device Quality Engineer to support complaint handling, PMS, vigilance, CAPA, risk management, and continuous product improvement.
Key Responsibilities
Manage and investigate medical-device complaints and customer feedback.Assess complaints for vigilance/adverse-event reporting requirements.Analyze PMS data and complaint trends to identify quality and safety signals.Manage and follow up on CAPA and effectiveness activities.Maintain traceability between complaints, PMS, CAPA, Risk Management, FMEA, Design Controls, and V&V.Support risk assessments and updates to risk-management documentation.Collaborate with Quality, Regulatory, R&D, Manufacturing, and Clinical teams.Support audits, regulatory inspections, and management reviews.
Requirements
5-7 years of experience in Medical Device Quality, PMS, Complaint Handling, Vigilance, CAPA, or Risk Management.Knowledge of ISO 13485, medical-device risk management, FMEA, CAPA, and complaint handling.Strong analytical, investigation, documentation, and communication skills.
Contract
Performance-based contract with potential extension based on performance, project requirements, and business needs.
How to Apply
Share your updated resume at:📧 contact@helion-es.com
Join HELION and contribute to safer, better medical-device products.
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