Sr Engineer Quality
Core
Set quality standards, lead testing/sampling methods, and manage vendor quality for medical device production processes.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Production processes, testing methods, and regulatory documentation (DMRs, 510K submissions)
Domain
Medical Devices / Quality Assurance
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 medical device industry experience
Technologies
MS Office Suite (Excel, Word, PowerPoint, Outlook)
Responsibilities
Manage process control and validation methods, design complex experiments for variation analysis, lead supplier quality programs, build regulatory documentation, investigate non-conformances, train team members
Seniority
Senior, hands-on IC