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Steve Buxton Location
Fehmarn, SH, DE
Steve Buxton Work
Commercial Vice President Healthcare @ (October 2022 - Present)
Managing Director @ CSA Group Healthcare Testing and Certification GmbH (August 2024 - Present)
Medical Device Consultant @ Buxton Consulting (October 2018 - October 2022)
Senior Consultant @ Alacrita Consulting (January 2010 - October 2022)
Global Vice President - Medical @ (February 2015 - October 2018)
Company Director and General Manager, Business Assurance - UK @ (January 2013 - January 2015)
Operations Director @ Atlas (January 2011 - January 2013)
RA and QA Director @ Enigma Diagnostics (July 2010 - December 2011)
Head of Medical Device and IVD Notified Body @ (November 1999 - March 2010)
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 Commercial Vice President Healthcare at CSA Group. Steve Buxton brings experience from previous roles at CSA Group Healthcare Testing and Certification GmbH, 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 4 emails and 2 mobile phone numbers on RocketReach.
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