Sr Engineer Quality- Operating Room Division
Core
Establish quality standards, validate processes, and manage supplier quality for medical device manufacturing.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Medical devices and components
Domain
Medical Devices / Manufacturing
Required skills
Statistical process control (SPC), Design control, Risk management, CAPA development, Supplier qualification, Regulatory compliance (21 CFR 820, ISO13485), Data analysis
Preferred skills
Six Sigma/Lean concepts, Advanced Excel (Pivot tables, reporting)
Technologies
MS Office Suite (Excel, Word, PowerPoint, Outlook)
Responsibilities
Design and perform experimental product testing and analysis; Lead investigations of product 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 CE technical files.
Seniority
Senior, hands-on IC
