Quality Engineer & Senior Quality Engineer (Complaints)
Company client has a fantastic opportunity for an experienced Complaints Senior Quality Engineer. Reporting to the Quality Manager, the successful candidate shall be responsible for for maintaining compliance of the Quality Management System and providing support to local departments to ensure the requirements of ISO 13485:2016 and CFR 21 Part 820 are implemented in full.
Some of the responsibilities include;
-Quality representative for one or more departments providing QA expertise, ensuring full QMS implementation, identifying opportunities for QMS improvements and leading the implementation of those improvements
-Coordination of QA activities associated with customer feedback (including complaint) investigations as well as QMS changes; batch release; process validation and / or supplier monitoring to meet the wider business goals.
-Organize, host and facilitate risk management related activities and ensure compliance of such activities to the applicable standards and regulations.
Knowledge and experience of working to ISO13485, FDA 21 CFR Part 820, MDSAP
Experience of working in a relevant role with a strong quality focus
Experience of post-launch IVD or medical device activities in a quality role