von: AXEPTA SA | localité: FribourgN: AXEPTASA
Our client, a growing and global medical device company located in Fribourg canton is looking for a QA coordinator to join their team for a new challenge.
This person will help to create a new manufacturing line and built the QA team.
- Lead the quality strategies in the context of a new manufacturing area
- Lead the Quality Assurance project team and help to uild up the new QA team for this area ( 2 people for 2025)
- Provide conformity and application of the QMS for the project.
- Ensure audits and regulatory inspections in the context of the project.
- Collaborate actively with the business partners.
- Provide leadership to build up the quality aspect of the project.
YOUR EXPERIENCE :
- Bachelor or Master in Biology, Pharmaceutical, medical device or related domain
- At least 5 years of experience in Quality Assurance, including ideally 3 years in a management role.
- Strong understanding of ISO Norm 13485, the European Directive 98/79/CE and FDA
- Strong experience in QA strategies in projects
- Strong leadership, people management and coaching skills.
- Experience with project management, Lean or Six Sigma projects preferred.
- French or German as a native language, with good knowledge of the other language.
- English on a professional level.