Katharina Falke

Quality Management Representitive @Dr. Fooke Laboratorien Gmbh

Neuss, DE

Maintenance and further development of the QM system in accordance with DIN EN ISO 13485 and DIN EN ISO/IEC 17025• Preparation and maintenance of technical documentation for Class B in vitro diagnostic medical devices in accordance with (EU) 2017/746• Evaluation of scientific literature and performance of post-market surveillance• Organisation of complaints and CAPA management• Support for research projects with regard to regulatory issues• Monitoring of standards and laws• Organisation of external audits by the notified body, inspections and site visits• Implementation of internal audits in accordance with DIN EN ISO 13485• Conducting training courses• Organising and implementing supplier management• Organising and implementing change controls• Processing customer enquiries on the subject of quality management• Evaluating customer satisfaction• Monitoring and implementing new legal and regulatory requirements• Safety officer

University of Salzburg

Bachelor of Science - BSc

University of Duisburg-Essen

PhD

Heinrich-Heine-University Düsseldorf

Master of Science - MSc