Posted: 5 February
Offer description
Seeking a dedicated Senior Quality Assurance Specialist to drive the implementation and continuous improvement of our Quality Management System. This hands-on role requires a mix of technical knowledge, practical application, and cross-functional leadership as we transition our innovative product through design, production, and regulatory milestones.
1. Drive daily QMS activities and lead process improvements
2. Collaborate with R&D on technical documentation development and review
3. Provide QA support for regulated manufacturing including equipment qualification process validation
4. Coordinate critical quality processes including internal audit programme Material Review Board NC/CAPA reviews complaint process
5. Interpret international standards ensuring compliance supporting supply chain team supplier development manufacturing requirements project expertise regulation submissions clinical investigations essential skills experience education bachelor's degree engineering science related field minimum 5 years recent experience medical device quality design assurance strong regulatory expertise analytical problem-solving skills communication influencing abilities collaborate effectively teams desirable bonus master's degree direct experience implantable devices complex process development highly regulated environment
