Jobs in life sciences

Quality compliance engineer/medical device auditor

Ref. QCE
Function: You are responsible for internal & external audits in terms of medical devices & combination products requirements.
Location: Between Brussels and Antwerp

The company:

You end up in a culture where ownership is an essential characteristic of every colleague. The company wants to excel today, but already thinks about tomorrow and responds proactively to it. At the company, we also strongly believe in teamwork. To realize the work you deliver, all workers need each other, help each other, challenge each other and share knowledge. "High quality" is the common thread in everything they do.

Job description:

As a quality compliance engineer/medical device auditor with the focus area medical device and combination products (MDCP), you are responsible for internal audits in terms of the MDCP requirements. You coordinate gap assessments against legislation, the company’s quality standards and inspection observations from other sites of the company. You coordinate external audits and government inspections with the team. Moreover, you are the compliance contact person of all MDCP expectations. You are critical so that processes are sharply analyzed, but at the same time a team player to look for workable compliant solutions in partnership with SMEs and production.

Requested competences and skills:

  • You have a scientific background (pharmacy, bio-engineering sciences, chemistry, microbiological or related sciences).
  • Minimum five years of experience in a pharmaceutical production environment
  • Experience in Medical Devices and Combination Products is a must.
  • Audit experience and experience in preparing and / or facilitating legal inspections (FDA, ANVISA, KFDA, EMA, ...) is an asset.
  • Knowledge of quality systems in the pharmaceutical industry. 
  • You are committed to quality and customer focus.
  • You have a pragmatic and hands-on approach.
  • You are strong in communication and stakeholder management. 
  • Dutch is a must (writing, reading and speaking).