Senior Engineer Quality
Core
Establish quality standards, validate processes, and manage supplier quality for medical device production to ensure product compliance and functionality.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Production processes, validated testing methods, regulatory documentation (DMRs, 510K submissions), and supplier quality programs.
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, root cause analysis, CAPA management, regulatory compliance (21 CFR 820, ISO13485), supplier qualification, risk management, documentation control
Preferred skills
Six Sigma/Lean concepts, advanced medical device industry experience
Technologies
MS Office Suite (Excel, Word, 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 regulatory submissions; coordinate product testing with internal and external laboratories.
Seniority
Senior, hands-on IC
