Ihre Aufgaben
The working student (m/w/d) – Risk management shall assist in the maintenance of Risk Management File (RMF) of all Dornier products in compliance with ISO 14971.
1. Maintain Risk management files
2. Update Risk management plans, Analyses and reports of Dornier sustenance products to comply with state of the standards
3. Perform strategic impact assessments as part of issue and change process
4. Establish traceability of defined control measures
5. Assist in new product developments
6. Support in initial setting up of Risk analysis for new development projects through pro-active co-ordination with stakeholders
7. Perform traceability checks to make sure defined risk control measures are adequately addressed in requirements and verified
8. Assist in usability engineering
9. Assist in performing user-related risk analysis as part of usability engineering file
10. Create Known Use Problem Analysis
11. Assist in updation/ creation of usability protocols and reports
Ihr Profil
12. ongoing technical university studies, preferable in medical technology or in a related field
13. interest in regulatory topics in the field of medical device technology and motivation to familiarize yourself with standards, guidelines, and quality requirements. Prior knowledge is desirable but not essential
14. Analytical and strategic thinking
15. Assertiveness
16. Good interpersonal skills
17. Problem-solving skills
18. Knowledge of MS office
19. Fluency in English, Knowledge in German is an advantage
Warum wir?
20. Personal induction plan and comprehensive onboarding
21. Flexible working hours
22. interesting tasks in a dynamic, international environment
23. Continuous training and development
24. Flat hierarchies
25. Attractive canteen
26. Free coffee, tea and water
27. Employee events
28. Charging stations for electric cars
29. Free language courses