Your Role
1. UDI database upload to US and in future EU
2. ensuring correct UDI database upload in South Korea (and Japan)
3. assessing future UDI requirements and implementing identified requirements into our existing Quality Management System - coordinating and/or executing data base upload to additional countries other than EU and US
4. UDI data collection and preparation for UDI database upload
5. being the contact person for work package(s) within the currently running UDI Project
6. being the contact person for collaboration on SAP Add ons (currently U.S. and EU) with stakeholders like Corporate IT, other ZEISS Strategic Business Units, and SAP Add on Supplier
7. being contact person / stakeholder for Life cycle concerning UDI / label activities like a) establishing print validation of UDI data matrix code at specific suppliers like GS1, b) ensuring UDI is adequately represented within Product Change Process including for SW products specifically including ensured required reporting times of changes are met, and c) ensuring UDI data availability (UDI-DI und Basic UDI-DI) for Technical Documentation and upload to relevant databases prior product rollout
8. maintaining the test plan for SAP Add on Testing in collaboration with Corporate IT and Master Data Management
9. being part of bug fixing regarding SAP Add ons (UDI)
10. proactively ensuring all functionalities of Add ons (UDI) are working to ensure upload
11. supporting creation/maintaining of relevant Standard Operating Procedures and Work Instructions
12. creation / maintenance of label specifications
13. creation / maintenance of label technical drawings
14. creation / maintenance of label reports - creation / maintenance of localized labels
Your Profile
15. You have completed a master's degree in medical technology, engineering, or equivalent
16. UDI requirements according to (EU) 2017/745 MDR are familiar to you
17. Knowledge of further country UDI requirements are an advantage
18. You are familiar with UDI database(s) including upload and data maintenance
19. Ideally, you already have some professional experience in medical technology, including but not limited to UDI and label requirements
20. If applicable, you have also already gained experience in quality management (ISO 13485, MDSAP)
21. You already have knowledge in project management including application of relevant tools and methods
22. You already have experience in the design and optimization of processes
23. You have a strong sense of quality and responsibility
24. You are characterized by a structured and goal-oriented way of working
25. You have a high level of motivation, a willingness to take on responsibility and enjoy familiarizing yourself with new topics
26. You have an agile mindset and openness to new working methods
27. You are characterized by a confident appearance, teamwork, and communication skills
28. Your way of working is independent, structured and implementation-oriented
29. You are proficient in the use of MS Office products
30. You have very good English writing and speaking skills, German would be a benefit
Your ZEISS Recruiting Team:
Megha Vishwakarma