Quality Management Specialist | Mitarbeiter (m/w/d) Qualitätsmanagement
LAUDA DR. R. WOBSER GmbH & Co. KG
Job Summary
As a Quality Management Specialist at LAUDA Medical, you will play a pivotal role in maintaining and developing the quality management system for our medical technology division. Your day-to-day responsibilities include managing non-conformity cases, performing root cause analyses, and overseeing CAPA projects to ensure effective resolution. You will be responsible for verifying batch records, managing customer complaints, and coordinating with suppliers. Furthermore, you will support regulatory affairs by conducting post-market surveillance and vigilance activities, while acting as a primary point of contact for regulatory authorities regarding registrations and documentation. This position is ideal for a detail-oriented professional who thrives in a collaborative, dynamic environment and wants to help shape the growth of a specialized medical company. You will enjoy a high degree of responsibility and the opportunity to influence quality processes in a future-oriented, modern workplace in Würzburg.
Required Skills
Education
Completed technical vocational training with further specialization in Quality Management (QM/QS/RA).
Experience
- At least 3 years of professional experience in a comparable quality management role within a regulated environment, preferably in medical technology.
- Practical experience with ISO 13485-compliant quality management systems.
- Experience in managing NC, CAPA, and customer complaints.
- Experience in planning, conducting, and following up on internal and external audits is highly desirable.
- Experience in Regulatory Affairs, specifically regarding post-market surveillance and vigilance, is considered an advantage.
Languages
Additional
- Must hold valid work authorization for Germany. Role is based in Würzburg.