QA specialist

QA Specialist

 

We are currently hiring.

Organisation

Indigo Diabetes is a high-tech medical devices scale-up. By exploiting ground-breaking photonics technology, Indigo Diabetes has developed an Active Implantable Medical Device (AIMD): World’s first invisible sensor for people living with diabetes to address their need for accurate glucose monitoring with an improved user experience. Their mission is to light up the life of millions of people living with diabetes 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 being started, the Senior Manufacturing QA Engineer will be highly involved in the further development of the quality and manufacturing processes.

 

Function

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
    • Writing manufacturing instructions

Requirements

We are looking for a motivated and driven candidate who has a hands-on mentality and at least two years of prior work experience in a similar role, in a manufacturing/ R&D environment. Additionally, the candidate should meet the following criteria: 

  • Bachelor’s degree in a technical area
  • Experience with further developing/implementing a QMS based on ISO13485, or assisting in this
  • Experience working with a highly technical medical device, preferably Class III AIMD
  • Eligible to work in the EU/Belgium
  • Team player, eager to learn and dedicated to a high degree of accuracy
  • Process-oriented and a structured way of working
  • Strong communicator to all levels of the organisation
  • Open to work in a dynamic start-up environment 

Offer

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 

Join us today!

Send us your motivation letter and CV (HR@indigomed.com)
We look forward to hearing from you!