QA/ra Manager

il y a 2 semaines

WatermaelBoitsfort, Région de Bruxelles, Belgique Covartim Temps plein

Functieomschrijving:


The
QA/RA Manager shall provide support for the development of innovative medical devices, as part of the COVARTIM QA/RA team.

(S)he will manage Quality Assurance and Regulatory Affairs activities such as, but not limited to:

  • Quality Management System implementation
  • Standards watch and gap analysis
  • Audits (internal/external)
  • Review and preparation of documentation packages for notified bodies, FDA, competent authorities

Location
Boulevard du Souverain 36, 1170 Watermael-Boitsfort (Brussels)

Function type
Full time open-ended

Background:

Min. 5 years of relevant experience in Medical Devices QA/RA functions.

Hard skills:

  • Good understanding of Medical Devices and IVD regulatory environment (directives, regulations)
  • Good knowledge of Medical Devices quality assurance (ISO 13485, 21 CFR) and relevant standards
  • Fluent in English and French/Dutch

Soft skills:

  • Quality and customerservice oriented
  • Focused on details
  • Teamplayer with strong communication skills
  • Ability to work crossprojects and excellent organizational skills
  • Autonomous and eager to learn
  • Strong interest in Lifesciences, Technology and Innovation
Ons aanbod

  • The opportunity to contribute to the development of products that will improve or save people's life
  • A valorizing job within an ambitious and growing company in a booming industry
  • A great team of enthusiastic people led by passionate experts in MedTech
  • A nice working environment in our new office located in Brussels, close to the forest of Soignes, a park, nice shops and restaurants, public transport connections and the E41
  • And of course, a good salary package and extra benefits
SolliciteerKyun Thibaut
Managing Director

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