:
1. CAPA Management: Lead the strategic oversight and execution of Corrective and Preventive Actions (CAPA) to resolve product-related issues, ensuring timely and compliant closure of CAPAs.
2. Regulatory Compliance: Ensure all product care activities adhere to regulatory guidelines, including IVDR and ISO13485, maintaining up-to-date product documentation and compliance records.
3. Cross-Functional Collaboration: nurture strong relationships with R&D, Production Planning, Marketing, QA/RA, and other departments to effectively run CAPA and NC processes, ensuring seamless operational flow and adherence to regulatory standards.
4. Continuous Improvement: Champion continuous improvement initiatives to enhance product quality and performance, applying root cause analysis to prevent recurrence of issues.
5. Audit and Documentation Management: Prepare for and lead defense in internal and external audits; manage and be responsible for the creation and maintenance of all product care documentation to ensure full regulatory compliance.
6. Team Leadership: Manage and develop a scientific team dedicated to product care activities, promoting professional growth and ensuring efficient and effective task completion.
Minimum Requirements/Qualifications:
7. Master’s degree in biology, Immunology, or a related scientific field, preferably with additional qualifications or certifications relevant to the IVD industry.
8. Profound experience in assay or medical device development, with a proven track record in managing product life cycles and compliance in a highly regulated environment.
9. Strong leadership and problem-solving skills, excellent organizational abilities, and proficiency in managing complex projects and initiatives.
10. Exceptional communication skills with fluency in English, both written and spoken, necessary for effective collaboration across diverse teams and collaborators. German is a plus.
What we offer:
11. Employment with an innovative, future-oriented organisation
12. Outstanding career and development prospects
13. Company pension scheme and other fringe benefits
14. Exciting company culture which stands for integrity, intensity, involvement and innovation