Sr Engineer Quality
Core
Establish quality standards, validate processes, and manage supplier quality for medical device production to ensure compliance and product functionality.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Production processes, validated testing methods, and compliant technical documentation
Domain
Medical Devices / Manufacturing Quality
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, regulatory compliance (21 CFR 820, ISO13485), supplier qualification, risk management, data analysis
Preferred skills
Six Sigma/Lean concepts, advanced Excel (Pivot tables, reporting)
Technologies
MS Office Suite (Word, Excel, PowerPoint, Outlook)
Responsibilities
Design and perform product testing and analysis to minimize defects; lead investigations of non-conformances and develop corrective actions; manage supplier quality programs and qualifications; ensure compliance with domestic and international regulations; generate and maintain Device Master Records and CE technical files.
Seniority
Senior, hands-on IC
