We are looking for a 2x half-time QA Specialist for both MONA Health & Synergia Medical.

Synergia Medical is a company that develops a next generation implantable device (CE Class 3) for the treatment of neurological disorders. The company is ISO 13485 certified. MONA.health is a company that develops AI software as a medical device (Class2a) to screen for eye disease leading to blindness. The 2 companies are looking for a Quality Specialist who could divide its time equally between the projects. The company is in the process of ISO 13485 certification.

Quality Assurance is at the center of all the decisions from product development to commercialization for Medical Device companies. We take this very seriously and youi will become a key person in the 2 organizations

A key position

Part of 2 small teams, you and your team are involved in the update and the improvement of the Quality System based on the ISO 13485.
You are also involved on regulatory topics and you ensure good communication with R&D team in order to develop products respecting regulatory and quality requirements.

Meaningful responsibilities

QMS and SOPs

  • You provide on-going guidance in the proper implementation and improvement of the Quality Management System
  • You write SOPs
  • Set up and maintain control and document procedures by ensuring all specified quality and documentation requirements.
  • Set up and maintain control and document procedures by ensuring all specified quality and documentation requirements


  • You perform gap analysis (standards and regulations, guidance)
  • You perform internal audits
  • You assist for the execution of the external audits


CAPA and non conformities

  • You manage CAPA and non-conformity process
  • You assist the coordination of complaints investigation and complaint handling


Product development

  • You support the revision of technical documentation in order to assure its regulatory & quality compliance
  • You support of the different steps for new device development: risk assessment, design control, labeling, etc.


What we expect for education and experience

  • University or High School Degree in Electronics Engineering, Biomedical Engineering,
  • Applied Mathematics Engineering or similar applicable to the job description
  • 2 years of relevant experience in QA functions in a regulated environment
  • A good knowledge of quality assurance (ISO 13485 or 9001) and relevant standards.
  • Good understanding of medical devices regulatory environment (FDA, MDR)
  • Good verbal and written communications skills in English and French/Dutch (speaking work environment)

This is you

  • Passionate about Biomedical Engineering, medical devices, AI, technology and innovation that can change the life of millions of patients
  • Thorough, hands on approach, you need to be autonomous
  • Showing attention to details, with the ability to cope with the complexities and tensions of a rapidly developing programme. In start ups the objectives can change rapidly as we like to “pivot”
  • Able and willing to work and evolve in a start-up atmosphere, it is very informal, fast moving and very direct
  • Organizational, flexibility, adaptability and responsiveness skills

If you think that you can take the challenge, we offer

 2 half-time open-ended contract and good salary packages
A friendly, dynamic and ever evolving start-up atmosphere and teams
The chance to get involved in the evolution of 2 great projects that have the potential to change the life of millions of patients