Quality Management System (QMS) Manager (m/f/x)

Descrizione del lavoro:

Seeing beyond - future of medical technology

For more than 100 years, ZEISS medical technology has been driving progress in ophthalmology and microsurgery. In ophthalmology, our solutions help to maintain and improve people's vision at every stage of their lives. In microsurgery, our solutions enable targeted interventions on diseased tissue so that small and sensitive organs continue to function optimally.
Medical technology from ZEISS supports medical professionals in improving the lives of patients worldwide. The fact that our actions have a direct impact on people's well-being is what drives us every day.

As Quality Management System (QMS) Manager (m/f/x) you are responsible for establishing, maintaining, and continuously developing an effective Quality Management System in compliance with applicable medical device regulations. The focus of the role is the coverage of Computerised System Validation (CSV) and the correct consideration of regulatrory requirements within the implementation phase of ZEISS FIT4 SAP S/4Hana Project.

Your Role

* You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements
* You ensure the compliant implementation and application of MED QMS requirements within SAP-supported processes in cooperation with partner teams
* You plan, drive, and document risk management activities across processes and projects
* You develop, implement, monitor, and document validation strategies for Computerised System, ensuring compliance with regulatory requierments
* You act as a subject matter expert and trusted advisor for quality and regulatory topics within cross-functional teams
* You act as interface for in and -external Partners and support all activities regarding CSV

Your Profile

* You have a completed university degree (Master's level) in natural sciences, engineering, business administration, or a comparable qualification
* You bring extensive years of professional experience in Quality Management within the medical device, pharmaceutical, or similarly regulated industry
* You possess solid knowledge of quality management standards and regulatory frameworks, in particular ISO 13485, MDR, and 21 CFR Part 11 or comparable requirements
* You have proven experience with Computerised System Validation (CSV)
* You are familiar with quality methods and tools such as FMEA, CAPA, 5-Why, and risk management
* You have experience with SAP and BPMN 2.0 (an advantage)
* You demonstrate a structured and analytical approach and are able to interpret complex technical and business information
* You work independently and in a solution-oriented manner with strong communication and organizational skills
* You are fluent in English; German language skills are an advantage

Your ZEISS Recruiting Team:Jana Benn