Senior Quality Engineer - Complaints Handling
Core
Handle complaints and conduct product investigations for medical devices, performing inspections and root cause analysis.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Complaint files, PMS plans, PSUR reports, and risk assessments for medical device products.
Domain
Medical Devices / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis, 7 QC tools, CAPA, engineering drawing, risk assessment, process flow review, inspection planning, measurement techniques, regulatory report creation (PMS/PSUR)
Preferred skills
Clinical report analysis, PMCF report analysis, national register analysis, process redesign, workflow development
Technologies
ISO 14971, ISO 9001, ISO 13485, FDA 21CFR Part 822/820, EUMDR
Responsibilities
Perform visual, functional, and dimensional inspections on field returned products; maintain accurate complaint files; review process flows and inspection plans; analyze clinical and PMCF reports to identify complaints; create PMS and PSUR reports; lead process improvement opportunities; mentor team members.
Seniority
Senior, hands-on IC
