Recommended expert
Reiner (S) Bandorf
Quality Manager, QMR and Lead Auditor for ISO 9001, ISO 13485, ISO 45001, MDR and GMP
Experience
Jan 2025 - Dec 2025
1 yearMonheim am Rhein, Germany
Director Quality
RECIPHARM AESICA PHARMACEUTICALS GmbH
Jan 2023 - Dec 2024
2 yearsDortmund, Germany
Senior Manager Inspection and Audit
Boehringer GmbH
Jan 2021 - Dec 2022
2 yearsHeilbad Heiligenstadt, Germany
Director Sales and Quality
CUREA MEDICAL GmbH
Jan 2016 - Dec 2020
5 yearsVienna, Austria
CSO Sales and Quality
JEDER MEDIZINTECHNIK GmbH
Summary
Strategic and business-minded Senior Quality Manager with over 20 years of leadership and line responsibility in the medical device, medtech and pharmaceutical industries. Extensive experience in establishing, developing and restructuring quality management systems in highly regulated environments (MDR, GMP, ISO 13485). Confident in regulatory and FDA inspections, and 1st, 2nd and 3rd-party audits.
Languages
German
NativeEnglish
AdvancedEducation
Oct 2014 - Jun 2015
IPE
Master of Science in Management · Management · Paris, France
Oct 2013 - Jun 2014
University of Whales
Master of Business Administration · Business Administration · United Kingdom
Oct 1989 - Jun 1991
GFS
State-certified business administrator · Business · Düsseldorf, Germany
Certifications & licenses
Auditor authorization extension for ISO 45001
LRQA GmbH
Auditor authorization for Medical Device GMP/GDP
Boehringer Ingelheim
Auditor authorization for ISO 9001 and 13485
LRQA GmbH
Certified Auditor for the medical device industry
Habmann Akademie
Certified Medical Device Expert
TÜV Hessen GmbH
Certified in Medical Device Regulatory Affairs
Habmann Akademie
Certified Process Auditor for Medical Devices
Habmann Akademie
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