Modis is looking, on behalf of a client, for an expert in quality.
- Manage, lead and coach the Quality Assurance System team.
- Ensure conformity and application of the Quality Management Systems across the facility.
- Manage customer audits and regulatory inspections.
- Drive strategies to continuously improve Quality Management Systems that enable to efficiently meet customer and regulatory requirements.
- Collaborate actively with the business partners to develop quality mindset.
- Monitor the foreseen regulatory evolutions to anticipate new requirements and get set for the future.
- Educational background in Biology, Pharmaceutical or related domain (BSc/MSc or equivalent education in Science).
- At least 5 years of experience in Quality Assurance in an In Vitro Diagnostics company or other related industry (Pharmaceutical, Biotechnology, Medical); including 3 years in a management role.
- Thorough understanding of ISO Norm 13485, the European Directive 98/79/CE and IVDR and the 21CFR820.
- Strong leadership, people management and coaching skills.
- Excellent team player with a strong ability to communicate within a multicultural environment, at all organizational levels, and with regulatory representatives
- Strong problem solving skills, with creative and strategic thinking.
- Experience with project management, experience in Lean or Six Sigma projects preferred. Certification Lean / 6 or Green Belt would be a plus.
- Either French or German as a native language. Good knowledge of the other language is a plus. English on a professional level.