Introduction
You will actively shape our quality management, ensure regulatory requirements and drive continuous improvements. In this responsible role, you will work closely with international teams and ensure the quality of our medical products in the long term.
These are your tasks:
- Structuring, maintaining and further developing the local quality management system including creating, updating and implementing SOPs and WIs
- Plan and execute changes in coordination with cross-functional, international teams
- Edit and track variances via TrackWise, including define and implement effective CAPA measures for the department
- Processing and tracking customer complaints in close cooperation with relevant interfaces and external suppliers
- Participation in hardware and software projects as an active quality function
- Prepare, accompany and actively participate in ISO 9001 / ISO 13485 / MDSAP certifications
- Plan, conduct, document and review internal and external (supplier) audits
This is what sets you apart:
- Successfully completed studies in medical technology, biotechnology, mechanical engineering or a comparable technical field
- Several years of professional experience in the medical technology industry, ideally with active medical devices and associated disposables
- Very good knowledge of ISO 9001, ISO 13485 and MDSAP standards as well as FDA requirements for the US market
- Experience in using TrackWise (Sparta System)
- Experience with internal and external audits; Lead Auditor certification is an advantage
- Fluent in German and English, both written and spoken
- Structured, pragmatic and independent way of working
Actively shape quality – apply now and become part of #futurefresenius!