The Quality Assurance Manager will oversee the company's Quality Management System (QMS), ensuring it aligns with evolving regulatory and business needs.
Responsibilities
* Own and manage the QMS, reporting performance to senior management
* Lead and supervise quality engineers and technicians
* Coordinate management reviews, quality reviews, and internal audit programmes
* Oversee supplier quality, including audits, SCARs, quality agreements, and performance monitoring
Requirements
* Degree in a scientific or technical discipline
* 4+ years' experience in the medical device or pharma industry
* In-depth knowledge of ISO 13485 and 21 CFR 820
* Strong quality systems, supplier management, and validation experience