Vigilance & Complaint Manager Medizintechnik (m/w/d)

Оccupation: Compliance manager

The Bertrandt Group has been offering for over 40 years Development solutions for the international automotive and aerospace industry and the machinery and plant engineering industries, Energy, medical technology and electrical industry in Europe, China and USA. Overall, our employees stand for deep know-how, future-oriented project solutions and high Customer orientation. Vigilance & Complaint Manager Medical Technology (m/w/d) Location: Oberkochen What awaits you: detection and evaluation of Claims: You accept customer complaints, document these carefully and assess their criticality and potential Effects on product safety. Ensuring compliance: They shall ensure compliance with reporting periods in accordance with local and Global requirements (e.g. EU MDR, FDA 21 CFR). Cause analysis and Countermeasures: Induce and coordinate causes analyses in cooperation with specialist departments and agree to the definition and Introduction of effective countermeasures to improve Product quality. Processing of safety correction measures Field (FSCA): They provide the process-compliant implementation of Security corrective measures in the field safe. Vigilance reports and Authorisation communication: You are responsible for the timely notification from vigilance activities to global health authorities and professional communication. Statistical analyses and Trend reports: They carry out statistical analyses and create meaningful trend reports for health authorities and Optimization of internal processes. Project management: Planning and control (cross-functional) subprojects in the field of vigilance and Complaint management. Quality management system: You are active maintaining our QM system according to ISO 13485:2016 with and engage in development, standardization and continuous improvement of vigilance and Complaint management processes. Internal cooperation: You work closely with other departments and contribute valuable work overarching processes, such as post-market surveillance. What? Bringing you: completed university studies, preferably in a technical or scientific study programme (e.g. Medical technology, pharmaceutical technology, optometry) or equivalent professional experience combined with a corresponding Graduate degree. Professional experience in the development and further development of quality management measures and Quality improvement in Vigilance or Post Market Surveillance, ideally in the field of medical technology English knowledge of word and writing is required; ideally bring knowledge of another foreign language. Knowledge of medical technology standards, especially in Quality management, such as ISO 13485:2016, as well as the relevant Laws and regulations, including MDR [for phone number see the original ad], 21 CFR 820, 803 and 806 Experience in the analysis of regulatory requirements and Use of databases Basic knowledge in statistics and Database analysis is advantageous knowledge of the creation of Dashboards with Power BI are desirable What we can: Flexible Working hours Internal Canteen Training Offers Discounts Parking Staff events Operational pensions and BU insurance Holiday and Christmas money JobRad Contact: Marina Humann Tel.: +[for phone number see the original ad] www.bertrandt.com/karriere

Joblocations:

73447 Oberkochen, BADEN_WUERTTEMBERG, GERMANY