Quality Engineer - Capital Equipment & Furnishings
Core
Set quality standards, validate processes, and manage supplier quality for medical device capital equipment and furnishings.
Role type
Quality Engineer (Medical Devices)
Builds
Production processes, testing methods, and regulatory documentation (DMRs, CE files, 510K submissions)
Domain
Medical Devices / Manufacturing
Required skills
Statistical process control (SPC), experimental design, CAPA management, supplier qualification, regulatory compliance (21 CFR 820, ISO13485), risk management
Preferred skills
Medical device industry experience
Technologies
MS Office Suite (Excel, Word, PowerPoint, Outlook)
Responsibilities
Design and perform product testing and analysis; lead supplier quality programs and investigations; ensure compliance with domestic and international regulations; develop corrective and preventive actions (CAPA) for non-conformances.
Seniority
Mid-level, hands-on IC