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Quality Assurance Engineer

  • Integrum
  • Göteborg
  • Publicerad: 11 juni, 2018
  • Fulltid

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 daniel.kremer@moveup.se!

 

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