Reiner (S) Bandorf
Quality Manager, QMR and Lead Auditor for ISO 9001, ISO 13485, ISO 45001, MDR and GMP
Experience
Director Quality
RECIPHARM AESICA PHARMACEUTICALS GmbH
Senior Manager Inspection and Audit
Boehringer GmbH
Director Sales and Quality
CUREA MEDICAL GmbH
CSO Sales and Quality
JEDER MEDIZINTECHNIK GmbH
Industries Experience
See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.
Experienced in Healthcare (7 years) and Pharmaceutical (3 years).
Business Areas Experience
The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.
Experienced in Quality Assurance (10 years), Sales (7 years), and Audit (2 years).
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
Education
IPE
Master of Science in Management · Management · Paris, France
University of Whales
Master of Business Administration · Business Administration · United Kingdom
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
Profile
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