Working at Freudenberg: We will wow your world!
Responsibilities:
1. Maintenance and further development of our quality management system in compliance with all relevant legal and normative requirements (ISO 13485, MDR, FDA and specific customer requirements)
2. Planning and coordination / execution of internal and external audits and certifications including the coordination of corrective and preventive actions (CAPA)
3. Carrying out risk analyses according to ISO 14971 in the team as FMEA moderator
4. Processing of regulatory affairs and product stewardship for the products of the Healthcare Division of Freudenberg Performance Materials
5. Quality-related support of change processes and the implementation of process optimizations, including any necessary qualification/validation activities, also as validation manager
6. Preparation and execution of training courses to ensure and raise awareness of quality and hygiene-related topics
7. Collaboration in national and international projects to ensure quality standards
8. Quality-related support and safeguarding of business relationships with external partners such as customers, suppliers and service providers
9. Maintaining quality-related documentation and supporting the creation of quality reports and KPIs
Qualifications:
10. Completed studies in the field of medical technology, quality management, engineering or a comparable qualification
11. First experience in quality management, especially in the area of ISO 13485, MDR, FDA and ISO 14971 and validation activities
12. Initial experience with internal and external audits and in dealing with authorities desirable
13. Structured, solution-oriented way of working with high problem-solving skills
14. Convincing and assertive personality with strong teamwork skills
15. Very good written and spoken German and English skills
16. Confident handling of MS Office and QMS software