Quality Manager | Quality Manager (m/w)
Bellini
Job Summary
The Quality Manager will take technical leadership of the Quality Management (QM) department, overseeing a team of five employees. A core responsibility is ensuring strict adherence to critical regulatory requirements, including RoHS, REACH, and EU Regulation 2017/745 for medical devices. You will be fully accountable for the Quality Management System (QMS), managing certification and customer audits, and driving process improvement through data analysis and management reviews. This role involves comprehensive documentation management (contracts, specifications) and leading the measurement laboratory, defining testing standards and error catalogs. You will also contribute to process engineering efforts, focusing on plant technology and technical problem-solving. The ideal candidate possesses a technical degree, extensive QM experience, particularly within the medical device sector, and proficiency with IT/ERP systems like SAP R3 and Q.Wiki. Success requires strong analytical skills, negotiation ability, and fluency in both German and English.
Required Skills
Education
Completed technical education (University of Applied Sciences or Higher Technical College degree)
Experience
- Professional experience in technical leadership and development of a QM team (5 employees)
- Several years of experience in Quality Assurance/Management within the Medical Technology sector
- Experience leading certification and customer audits
- Professional experience in defining and documenting processes to ensure QMS conformity
- Experience managing deviation management and QM documentation
Languages
Additional
- Strong negotiation skills and ability to clearly communicate complex technical matters. Must demonstrate an active, solution-oriented approach utilizing efficient and practical methods.