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QA Specialist

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By exploiting ground-breaking photonics technology, this high-tech medical devices scale-up has developed an Active Implantable Medical Device (AIMD) that can address the patient’s need for accurate monitoring with an improved user experience and is currently looking for a QA Specialist. Their mission is to light up the life of millions of people and their families through innovative medical technologies. As the device has not been introduced to the market yet, and the first-in-human clinical research studies are getting started, the QA Specialist will have a crucial role in the go-to-market preparations.

Details
  • Medical Devices
  • Quality/RA
  • Ghent
  • 40 hours p/week
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Our subject matter

About your role

This is how you will make the difference

As a QA Specialist, you will work in a team of currently four QA professionals and report to the VP Quality Assurance. As this is a small team in a scale-up environment, this role requires a hands-on work ethic. You will perform several tasks with the main goal to set-up the QMS and write all necessary procedures, this includes tasks related to:

  • Ensuring audit readiness
  • Reviewing current quality procedures and processes and optimising where needed
  • Improving and developing of the QMS in close cooperation with other functions, such as manufacturing and supply chain quality management
  • Writing Standards Operating Procedures (SOPs)
  • Execute and monitor QMS procedures like document management/CAPA/Audit/training risk management, together with the quality team
  • Optimising and digitalising quality management tooling
  • Supporting other department is execution of their quality procedures including: writing and building technical files and writing manufacturing instructions

What we offer

What's in it for you

This role offers:

  • A high level of responsibility
  • A big role in the further building of the quality department of a promising medical devices scale-up
  • A competitive salary package with market-conform fringe benefits, dependent on experience
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