Engineer Quality
Core
Independently set quality standards, develop testing methods, and manage vendor quality for medical device production processes.
Role type
Quality Engineer (Medical Devices)
Builds
Production processes, testing methods, and regulatory documentation (DMRs, 510K submissions)
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 development, supplier quality management, regulatory compliance (21 CFR 820, ISO13485), risk management
Preferred skills
Medical device industry experience, advanced Excel skills
Technologies
MS Office Suite, statistical analysis tools
Responsibilities
Design and perform product testing and analysis to minimize defects; lead supplier qualifications and corrective actions; ensure compliance with domestic and international regulations; lead investigations of non-conformances and develop CAPA; generate and maintain Device Master Records and CE technical files.
Seniority
Mid-level, hands-on IC
