Quality Engineer II
Core
Develops, modifies, applies and maintains quality standards and protocols for processing materials into finished medical device products.
Role type
Quality Engineer II (Medical Devices)
Builds
Medical devices and manufacturing processes
Domain
Healthcare / Medical Device Manufacturing
Required skills
Quality engineering principles, Statistical analysis (ANOVA, Capability Analysis, DOE), Process validation, Test method validation, FMEA, Risk management, CAPA management, NCMR management
Preferred skills
Six Sigma (DRM), Mechanical/Industrial/Biomedical Engineering background, Medical device manufacturing experience
Technologies
Statistical tools, Quality Management Systems
Responsibilities
Develop and maintain quality standards and protocols for material processing; Collaborate with engineering and manufacturing to ensure quality standards; Design and specify inspection and testing mechanisms; Conduct quality assurance tests and statistical analysis; Ensure corrective measures meet reliability standards and documentation compliance.
Seniority
Mid-level, hands-on IC