Quality Engineer II
Core
Prepare and compile post-market safety data into Periodic Safety Update Reports (PSURs), analyze complaint trends to detect safety signals, and draft adverse event reports for medical devices.
Role type
Quality Engineer II (Post-Market Surveillance & Safety Reporting)
Builds
Regulatory-compliant safety reports and signal evaluations for medical device products
Domain
Healthcare / Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Post-market surveillance processes, adverse event reporting, risk management principles, hazard analysis, statistical evaluation, regulatory standards knowledge (ISO 13485, 21 CFR 820/11, EU MDR)
Preferred skills
Mechanical/Biomedical Engineering background, experience with signal detection and evaluation, CAPA actions
Technologies
ISO 9001, ISO 13485, ISO 14971, 21 CFR part 820, 21 CFR part 11, EUMDR
Responsibilities
Compile PSURs, monitor and analyze product complaint trends, assess complaints for completeness, conduct statistical evaluation of safety signals, draft signal evaluation and adverse event reports, liaise with cross-functional teams for investigations, ensure compliance with global regulatory standards
Seniority
Mid-Senior, hands-on IC