Stefan Klein
Mdr Site Auditor, Mdr Product Reviewer @Qmd Services
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WORK HISTORY
Mdr Site Auditor, Mdr Product Reviewer @Qmd Services
EDUCATION
Hochschule München University of Applied Sciences
Dipl. Ing, Medical Device Engineering
SKILLS
ABOUT STEFAN KLEIN
25 years experience in Quality & Regulatory Management Systems (ISO 13485/9001/21CFR820) of medical device industry.Development and implementation of Quality and Regulatory Management Strategy.Implementation and certification of multi site Quality Management System according to ISO 13485, MDSAP and FDA requirements.Specialties: MDD, IVD, MDR, IVDR, 21CFR820, MDSAP, ISO 13485, 510(k), ISO 14971 (Risk Management), Quality Management System, Internal Audits,ISO 19011, Supplier Audits, ISO 14001, EMAS, REACH, China RoHS, Compliance Management System, Regulatory Affairs.
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