Quality Assurance Manager ROCGJP00028415
Duration of the contract: 30.09.2026
Tasks & Responsibilities:
- Review and approve content from day-to-day business in various topics (change control, nonconformities, project, product and process documents and other specification and verification documents relevant to production)
- Support and improve our local and global processes to ensure that they comply with regulatory requirements or best practices.
- Act as a coach in the team and actively help to develop individual skills/expertise so that future business requirements are covered.
- Preparation, implementation and follow-up of internal and external audits.
- Responsible for the quality-related aspects of design or technical product transfer projects to production to ensure product quality and compliance.
- Llead and/or support global projects/initiatives in the area of quality management or operations and engage as a process consultant within our QMS.
The perfect candidate has a degree in engineering or natural sciences and over 5 years of experience in quality management of medical devices/IVDs and their regulatory requirements. The person also has experience in project management and audits.
Must Haves:
- Fluent German and English
- Completed technical or scientific degree or many years of professional experience in a technical field. (or similar)
- At least 5 years of experience in quality management of medical devices / IVDs and their regulatory requirements (in particular ISO 13485)
- Ability to make decisions outside the comfort zone or area of responsibility, to develop solutions and to implement them independently (**)
- Strong and convincing communication skills in German and English and can use them in a complex environment
- Experience in project management
- Familiar with new, agile working methods and challenge conventional thought patterns
- Audit experience and an excellent understanding of QMS
Über die Firma
