Sr Engineer Quality
Core
Establish quality standards, validate processes, and manage supplier quality for medical device manufacturing and regulatory compliance.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Production processes, testing methods, and regulatory documentation (DMRs, 510K submissions)
Domain
Medical Devices / Quality Assurance / Regulatory Compliance
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 qualification, regulatory compliance (21 CFR 820, ISO13485), 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; collaborate with suppliers on quality problems and CAPA; ensure compliance with domestic and international regulations; generate and maintain Device Master Records and CE technical files; coordinate product testing with internal and external laboratories.
Seniority
Senior, hands-on IC
