Sr Engineer Quality
Core
Setting quality standards, developing testing methods, and ensuring compliance with regulations for medical device production processes.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Production processes, testing methods, and regulatory documentation for medical devices
Domain
Medical Devices / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical process control (SPC), experimental design, CAPA management, supplier quality management, regulatory compliance (21 CFR 820, ISO13485), risk management, design control
Preferred skills
Six Sigma/Lean concepts, advanced Excel (Pivot tables, reporting)
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