Stefan Fernsner
Senior Quality Manager Design Control @Roche
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WORK HISTORY
Senior Quality Manager Design Control @Roche
Mannheim, DE
Design Quality and Design Control of IVDR Projects (Assay and Reagent Development,Instrument Hardware and Software); Process Improvement; Stakeholder Management
EDUCATION
FAU Erlangen-Nürnberg
Master in Health and Medical Management - MHMM, Health/Health Care Administration/Management
Karlsruhe Institute of Technology (KIT)
Dr.-Ing., Biomedizintechnik/Medizintechnik
Karlsruhe Institute of Technology (KIT)
Dipl.-Ing., Elektro- und Informationstechnik
Universität des Saarlandes
Grundstudium - Vordiplom, System- und Elektrotechnik
ABOUT STEFAN FERNSNER
Passionate Medical Device Industry Professional with over 15 years experience in the fields of Quality, Regulatory and Operations. Experience with Medical Devices and In-Vitro Diagnostics of all classes and kinds (Hardware, Software, active, non-active, sterile a.s.o). Background in Research, Software and Electronics, but always curious and willing to learn something new. Used to using established Methods and looking for new Methods to manage teams and place innovative products and solutions on the market and master technical and operational challenges in start-ups as well as in the coperate world.
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