PMS Quality Assurance Engineer
Core
Ensuring the safety and effectiveness of medical devices after market launch by monitoring performance, analyzing data, and reporting findings to regulatory authorities.
Role type
Post-Market Surveillance Quality Assurance Engineer
Builds
Post-market surveillance reports, risk assessments, and corrective action plans for medical devices.
Domain
Medical devices / Neurovascular and peripheral vascular / Regulatory compliance
Deliverable
client delivery
Required skills
Post-market surveillance planning, data analysis from complaints and adverse events, risk analysis, Health Hazard Evaluation, regulatory reporting, root cause analysis, process procedure development
Preferred skills
Medical device risk management, familiarity with clinical applications
Technologies
Microsoft Office, database software
Responsibilities
Develop post-market surveillance plans, collect and analyze post-market data, perform risk analysis and health hazard evaluations, prepare regulatory reports, collaborate with cross-functional teams, maintain process procedures
Seniority
Mid-level, hands-on IC
