Vigilance and Complaints Manager in Oberkochen bei ZEISS Group

Vigilance and Complaints Manager (f/m/x) in Oberkochen bei ZEISS Group

ZEISS Group

Your Role

Contribute to the Development of Vigilance and Complaint Process
Documentation, analysis and evaluation of complaints
Analyze and evaluate customer complaints and initiate the necessary measures to improve product quality. Coordinate and implement timely incident reports to the respective authorities
Reporting to authorities according to local and global regulations (e.g. EU Regulation 2017/745 (MDR), FDA 21CFR820, 803, 806 etc.)
Carry out communication with customers, authorities and partners on complaints and vigilance is-sues
Organization of action and safety corrective action in the field (FCA and FSCA)
Contribution to creation of post-market surveillance plans and reports and initiate necessary product improvements
Preparation of quality statistics and quality documents (SOPs, work instructions, forms)
Contribute to the maintenance of the QM system according to ISO 13485:2016 and participation in audits
Contribute to Vigilance and Complaints Management further standardization and continuous improve-ment taking into account the further development of global standards and regulations
Prepare and evaluate trend reports as part of post-market analyses and initiate necessary product improvements

Your Profile

University education in science or engineering in the field of medical technology, industrial engineering, electrical engineering, biology, chemistry or a comparable qualification
First professional experience in the field of vigilance and in the development of quality improvement measures, ideally in the field of medical technology
Experience in dealing with international customers and partners worldwide
Knowledge of European and German medical device law, FDA and other applicable regulations for Medical devices
Knowledge of normative requirements and laws in the field of medical technology (standards EN ISO 14971, 13485, IEC 60601-1, IEC 62304, EU MDR, US CFR, etc.)
Business fluent in written and spoken English - another foreign language is an advantage
Very good knowledge of MS Office and common software tools
Very good ability to work in international and interdisciplinary teams