Senior QSAT Engineer
Core
Lead product quality investigations, root cause analysis, and equipment qualification/validation for cancer diagnostic pathology products.
Role type
Senior Quality Systems and Assurance Testing (QSAT) Engineer
Builds
Production quality systems and validated manufacturing equipment for cancer diagnostics
Domain
Medical device / Clinical diagnostics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root cause analysis (Six Sigma, Lean, 5 Whys, Fishbone), CAPA management, GxP compliance, Risk assessment (FMEA), Equipment qualification, Regulatory standards (ISO 13485, FDA 21 CFR Part 820, ISO 14971)
Preferred skills
Production equipment validation (filling lines, washing machines), Design control, Design transfer
Technologies
ISO 13485, FDA 21 CFR Part 820, ISO 14971, FMEA
Responsibilities
Lead product quality investigations from complaints and post-market surveillance, Drive root cause investigations for product and manufacturing issues, Review and approve CAPAs, Guide qualification and validation of manufacturing equipment and processes, Support R&D compliance during design changes, Act as subject matter expert for strategic quality initiatives
Seniority
Senior, hands-on IC