QA Engineer 2
Core
Implement and maintain quality assurance protocols for processing materials into finished products, ensuring compliance with GLP, GMP, ISO, and Six Sigma standards while leading complex investigations.
Role type
Senior IC Quality Engineer (Medical Devices)
Builds
Medical devices (CGM systems) for patients with diabetes
Domain
Medical device manufacturing / Biosensing technology
Required skills
FDA QSR knowledge, ISO 13485 compliance, risk management, statistical tools, root cause analysis, validation methodologies, problem-solving
Preferred skills
Six Sigma, mentoring engineers, cross-functional leadership, coaching
Technologies
GLP, GMP, ISO, Six Sigma
Responsibilities
Implement and maintain quality assurance protocols, complete investigations into nonconformances, assist in high-visibility quality engineering projects, identify systemic issues and drive corrective actions, mentor engineers and shape best practices
Seniority
Mid-Senior, hands-on IC with leadership responsibilities