Sr Engineer Quality
Core
Setting quality standards, managing process control and validation, and leading supplier quality programs for medical device manufacturing.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Production processes, testing methods, and regulatory documentation (DMRs, 510K submissions)
Domain
Medical Devices / Manufacturing Quality
Required skills
Statistical Process Control (SPC), Design of Experiments, CAPA management, Regulatory compliance (21 CFR 820, ISO13485), Supplier Quality Management, Risk Management, Data Analysis
Preferred skills
Six Sigma/Lean concepts, Advanced Medical Device industry experience
Technologies
MS Office Suite (Excel, Word, PowerPoint, Outlook)
Responsibilities
Design and perform experimental product testing and analysis; Lead investigations of product and process non-conformances; Direct collaboration with supplier representatives on quality problems; Ensure compliance with domestic and international regulations; Manage the development and implementation of methods for process control and validation
Seniority
Senior, hands-on IC