As a new position it requires external expertise in the area of FDA QSMR. Role Overview The Quality Systems Engineer will initially lead a QMS transformation project, ensuring compliance with US FDA QSMR and other regulatory requirements. […]
Key Responsibilities Lead the development and enhancement of the companys QMS to ensure full compliance with FDA QSMR and ISO 13485. Conduct gap assessments, identifying areas for improvement and implementing best-in-class quality practices. […]
Conduct internal quality audits to ensure compliance with ISO 13485 and Good Manufacturing Practices (GMP). Post...