Software Quality Engineer Healthcare

  • Healthcare
  • Zwijnaarde, Belgium

Software 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 Software 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 software certification.

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

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

    • Organizing and documenting quality (acceptance and integration) tests of software

Requirements

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

    • ISO/IEC 62304 knowledge and experience, and knowing how to guide us in further implementing and improving it.

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

    • Experience in documenting steps of a software development process, knowing how to work at continuous improvement of our quality of delivery and traceability of requirements and change requests.

Nice to haves

  • Experience in (co)writing subsidy documentation.

  • Experience in ISO13485 Medical Device environments

  • ISTQB® CTFL