Sr. Design Quality Engineer
Core
Primary QA owner for assigned medical device projects, driving design quality activities from concept through commercialization to ensure compliance with design controls, risk management, and regulatory requirements.
Role type
Senior Design Quality Engineer (Medical Devices)
Builds
Medical device products
Domain
Medical devices / Semiconductor
Deliverable
client delivery
Required skills
Design controls, Risk management, Verification and validation, eQMS management, Test method validation, Regulatory compliance (IEC 62304, IEC 62366-1), FMEA, Gauge R&R studies
Preferred skills
Startup environment experience, Fast-paced product development
Technologies
eQMS, Software validation tools
Responsibilities
Execute quality assurance activities throughout product design and development, Support development and review of design control deliverables, Author and drive verification and validation activities, Author and support test method validation activities, Author and drive risk management activities, Collaborate with cross-functional teams to ensure design control compliance
Seniority
Senior, hands-on IC