Senior Quality Engineer - NAMIC
Core
Setting quality standards, validating processes, and managing supplier quality for medical device production to ensure compliance and product functionality.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Production processes, validated testing methods, and compliant technical documentation for medical devices.
Domain
Medical Devices / Manufacturing 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, root cause analysis, CAPA management, regulatory compliance (21 CFR 820, ISO13485), vendor qualification, risk management, MS Excel (advanced)
Preferred skills
Six Sigma/Lean concepts, 5+ years in Medical Devices/Drugs
Technologies
MS Office Suite (Word, Excel, PowerPoint, Outlook)
Responsibilities
Develop and implement process control and validation methods; design complex experiments to analyze variation; lead supplier quality programs and investigations; generate Device Master Records and CE technical files; coordinate product testing with internal/external labs; lead investigations of non-conformances and develop corrective actions.
Seniority
Senior, hands-on IC