Quality Engineer Healthcare

  • Healthcare
  • Zwijnaarde, Belgium

Quality Engineer Healthcare

Job description

Robovision is a rapidly growing company at the forefront of AI development in Europe and beyond. We are active in a number of verticals, and for our healthcare vertical we’re developing state of the art AI algorithms that will improve the outcomes and standard of care in hospitals.

For this activity, we are looking for a Quality Engineer who can watch over the quality and regulatory documentation of our developments, and guide us - with the help of external experts - towards certification.


Job requirements

Responsibilities

  • Be the key person keeping Robovision Healthcare on the track to successful medical certification.

  • Working closely together with our development team, development partners, and regulatory partners, you hold the pen to ensure our developments are fully documented in line with regulatory requirements.

  • Working closely with a quality director, can implement existing procedures, and - if needed - suggest improvements.

  • Organizing and documenting quality tests of software

Requirements

  • Multiple years experience in ISO regulated quality environments, ideally in a medical device context such as ISO 13485

  • ISE 62304 knowledge and experience, and knowing how to guide us in implementing it.

  • Experience in documenting steps of a software development process, improving our quality and traceability.

  • Having an affinity for software through education or experience, and capable to document and describe requirements and other


Nice to haves

  • Experience in (co)writing subsidy documentation.

  • Experience in ISO13485 Medical Device environments