We’re looking for a Quality Engineer II to support quality activities across product development, batch release, audits, and supplier management. This is a hands-on role supporting the QMS and ensuring regulatory compliance (ISO 13485 / FDA).
Key Responsibilities:
Support QMS activities (CAPA, audits, training, documentation).
Manage batch release and ensure product compliance.
Work with suppliers on quality agreements and performance reviews.
Support testing, validations, and first article inspections (FAI).
Use tools like RCA, FMEA, and CAPA to solve quality issues.
Provide quality support from development through to commercial stage.
Requirements:
Degree in Quality, Engineering, or Science.
3–5 years in medical devices, ideally with FDA/MDR experience.
Strong knowledge of ISO 13485 and quality tools.
Auditor certification a bonus.
