2013 -2015 Company Director and General Manager, Business Assurance - UK @
2011 -2013 Operations Director @
2010 -2011 RA and QA Director @
1999 -2010 Head of Medical Device and IVD Notified Body @
Steve Buxton Education
University of London
Bachelor of Science (Biology)
1982-1985
Steve Buxton Skills
ISO 13485
Quality Systems
FDA
Regulatory Affairs
Medical Devices
Process Validation
Design Control
Quality Assurance
R&D
510 K
ISO 14971
Validation
GMP
Diagnostics
CAPA
Biotechnology
ISO
Quality Auditing
Quality Management
21 CFR Part 11
cGMP
GLP
Continuous Improvement
Life Sciences
QSR
SOP
Microbiology
CE marking
Manufacturing
Clinical Trials
GCP
Auditing
Lean Manufacturing
Cross-functional Team Leadership
Product Development
Regulatory Submissions
Process Improvement
Process Development
Change Control
Healthcare
Start-ups
Documentation
SPC
Lifesciences
Quality System
Software Documentation
Iso 9000
Regulatory Requirements
Quality Control
Testing
Start Ups
Strategy
Cross Functional Team Leadership
Data Analysis
Leadership
Steve Buxton Summary
Steve Buxton, based in Fehmarn, SH, DE, is currently a Managing Director at CSA Group Healthcare Testing and Certification GmbH. Steve Buxton brings experience from previous roles at CSA Group, Buxton Consulting, Alacrita Consulting and TÜV Rheinland. Steve Buxton holds a 1982 - 1985 Bachelor of Science in Biology @ University of London. With a robust skill set that includes ISO 13485, Quality Systems, FDA, Regulatory Affairs, Medical Devices and more. Steve Buxton has 5 emails and 2 mobile phone numbers on RocketReach.
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