For our client, a company in the precision engineering industry (medical technology), we are looking for someone with your expertise in the position of Vigilance & Complaint Manager (m/f/d) at the locations Berlin/ Jena or Oberkochen with the following focus:
Here's what we offer
1. Attractive salary and long-term job security through group affiliation
2. Up to 30 days vacation per year
3. Contribution to company pension scheme after end of probationary period
4. Extensive social benefits, including Christmas and vacation bonuses
5. Reimbursement of travel expenses
6. As a rule, a permanent employment contract
7. Good chances of being taken on by our business partners
8. Tailored further training opportunities and free language courses
9. A wide range of employee benefits
Your tasks
10. Recording complaints, assessing criticality and ensuring compliance with reporting deadlines in accordance with local and global requirements (e.g. EU MDR, FDA 21 CFR)
11. Initiating root cause analyses and coordinating with specialist departments to define and initiate countermeasures to improve product quality
12. Process-compliant processing of safety corrective measures in the field
13. Timely reporting of vigilance activities and communication with global authorities
14. Performing statistical analyses and preparing trend reports for health authorities and internal processes
15. Planning and management of (cross-functional) sub-projects
16. Contributing to the maintenance of the QM system according to ISO 13485:2016 and the development, standardization and continuous improvement of vigilance and complaint management processes
17. Collaborating with other departments and contributing to overarching processes, e.g. post-market surveillance
Your profile
18. Completed university degree, preferably in a technical or scientific field (e.g. medical technology, pharmaceutical technology, optometry) or equivalent professional experience in combination with a relevant degree.
19. Professional experience in the development and further development of quality management and quality improvement measures in the area of vigilance or post market surveillance, ideally in the field of medical technology.
20. Fluency in written and spoken English is required; ideally you will have knowledge of another foreign language.
21. Sound knowledge of medical device standards, especially in quality management, such as ISO 13485:2016, as well as relevant laws and regulations, including MDR 2017/745, 21 CFR 820, 803 and 806
22. Experience in analyzing regulatory requirements and using databases
23. Basic knowledge of statistics and database analysis is an advantage
24. Knowledge of creating dashboards with Power BI is desirable
25. An independent, structured and sustainable way of working rounds off your profile