Your Role
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Contribute to the Development of Vigilance and Complaint Process
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Documentation, analysis and evaluation of complaints
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Analyze and evaluate customer complaints and initiate the necessary measures to improve product quality. Coordinate and implement timely incident reports to the respective authorities
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Reporting to authorities according to local and global regulations (e.g. EU Regulation 2017/745 (MDR), FDA 21CFR820, 803, 806 etc.)
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Carry out communication with customers, authorities and partners on complaints and vigilance is-sues
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Organization of action and safety corrective action in the field (FCA and FSCA)
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Contribution to creation of post-market surveillance plans and reports and initiate necessary product improvements
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Preparation of quality statistics and quality documents (SOPs, work instructions, forms)
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Contribute to the maintenance of the QM system according to ISO 13485:2016 and participation in audits
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Contribute to Vigilance and Complaints Management further standardization and continuous improve-ment taking into account the further development of global standards and regulations
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Prepare and evaluate trend reports as part of post-market analyses and initiate necessary product improvements
Your Profile
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University education in science or engineering in the field of medical technology, industrial engineering, electrical engineering, biology, chemistry or a comparable qualification
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First professional experience in the field of vigilance and in the development of quality improvement measures, ideally in the field of medical technology
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Experience in dealing with international customers and partners worldwide
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Knowledge of European and German medical device law, FDA and other applicable regulations for Medical devices
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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.)
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Business fluent in written and spoken English - another foreign language is an advantage
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Very good knowledge of MS Office and common software tools
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Very good ability to work in international and interdisciplinary teams
Your ZEISS Recruiting Team:
Marina Löw
