Vigilance & Complaint Manager (m/w/x)

Vigilance & Complaint Manager (m/w/x), münster

münster, Germany

Join ZEISS and be part of a company that values innovation, growth, and societal contribution. We foster an open, modern environment with numerous development opportunities, driven by expertise and teamwork, underpinned by our long-term vision to advance science and society.

About ZEISS Medical Technology:

For over 100 years, ZEISS has been at the forefront of medical technology, advancing ophthalmology and microsurgery. Our solutions help preserve and improve vision and enable precise interventions in delicate tissues, supporting healthcare professionals worldwide to enhance patient lives.

Key Responsibilities:

1. Capture and evaluate complaints, assess criticality, and ensure compliance with reporting deadlines according to local and global regulations (e.g., EU MDR, FDA 21 CFR).
2. Conduct root cause analyses and coordinate with relevant departments to implement corrective actions to improve product quality.
3. Handle safety corrective actions in the field in accordance with process standards.
4. Ensure timely reporting of vigilance activities and communicate with global authorities.
5. Perform statistical analyses and prepare trend reports for health authorities and internal processes.
6. Plan and manage cross-functional sub-projects.
7. Contribute to maintaining the QM system per ISO 13485:2016 and to the development, standardization, and continuous improvement of vigilance and complaint management processes.
8. Collaborate with other departments and support cross-departmental processes, e.g., Post-Market Surveillance.

Minimum Qualifications:

• University degree, preferably in engineering or natural sciences (e.g., Medical Technology, Pharmaceutical Technology, Optometry) or equivalent professional experience combined with relevant education.
• Experience in developing and improving quality management measures, particularly in vigilance or post-market surveillance, ideally within medical technology.
• Fluent in English, both spoken and written; knowledge of additional languages is a plus.
• Strong knowledge of medical device standards, especially ISO 13485:2016, and relevant laws such as MDR 2017/745, 21 CFR 820, 803, and 806.
• Experience analyzing regulatory requirements and utilizing databases.
• Basic knowledge of statistics and data analysis is advantageous.
• Knowledge of creating dashboards with Power BI is desirable.
• Self-motivated, structured, and sustainable working style.