Junior UDI

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

Your ZEISS Recruiting Team: