Integrum is marketing the OPRA Implant System, a bone-anchored system based on osseointegration, where the prostheses are directly attached to the bone, thereby avoiding the use of a socket. The system is clinically well tested and, since 1990, it has helped more than 400 individuals to improve their quality of life. The company is currently looking for a QA Engineer to ensure quality compliance within the fields of post-market surveillance, supply chain, non-conformity and CAPA and product release. Responsibilities include but is not limited to;
-develop and maintain system for collecting, analyzing and providing reports in non-conformity and complaint statistics to the organisation
-identify and report any quality or compliance concerns and take immediate corrective action as required
-drive and follow up complaint cases and work with authorites regarding vigilance/medical device reporting
-actively participate in reviewing the specification of documents for purchasing products and components
-responsible for reviewing batch documentation for final product release
-reviewing and approving documents necessary for achieving CE-mark and product approval
-actively participate in validation projects at suppliers to secure production
-authority to approve and close non-conformities
-authority to approve or reject final product release
-authority to close complaints
As a succesful candidate you a couple of years experienece from similar tasks within the medtech industry. A background from both small and large organisations is preferred. You thrive in a small organisation with a broad range of responsibilities.
Please contact Daniel Kremer for questions or send your CV to firstname.lastname@example.org!