Your Role

• UDI database upload to US and in future EU

• ensuring correct UDI database upload in South Korea (and Japan)

• 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

• UDI data collection and preparation for UDI database upload

• being the contact person for work package(s) within the currently running UDI Project

• 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

• 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

• maintaining the test plan for SAP Add on Testing in collaboration with Corporate IT and Master Data Management

• being part of bug fixing regarding SAP Add ons (UDI)

• proactively ensuring all functionalities of Add ons (UDI) are working to ensure upload

• supporting creation/maintaining of relevant Standard Operating Procedures and Work Instructions

• creation / maintenance of label specifications

• creation / maintenance of label technical drawings

• creation / maintenance of label reports - creation / maintenance of localized labels

Your Profile

• You have completed a master's degree in medical technology, engineering, or equivalent

• UDI requirements according to (EU) 2017/745 MDR are familiar to you

• Knowledge of further country UDI requirements are an advantage

• You are familiar with UDI database(s) including upload and data maintenance

• Ideally, you already have some professional experience in medical technology, including but not limited to UDI and label requirements

• If applicable, you have also already gained experience in quality management (ISO 13485, MDSAP)

• You already have knowledge in project management including application of relevant tools and methods

• You already have experience in the design and optimization of processes

• You have a strong sense of quality and responsibility

• You are characterized by a structured and goal-oriented way of working

• You have a high level of motivation, a willingness to take on responsibility and enjoy familiarizing yourself with new topics

• You have an agile mindset and openness to new working methods

• You are characterized by a confident appearance, teamwork, and communication skills

• Your way of working is independent, structured and implementation-oriented

• You are proficient in the use of MS Office products

• You have very good English writing and speaking skills, German would be a benefit

Ihr ZEISS Recruiting Team:

Megha Vishwakarma