Principal @ Bright Quality Solutions (September 2016 - Present)
Sr. Director RA and QA and Sterilization @ IsoAid (September 2019 - November 2025)
Director of Industry Solutions @ (March 2019 - September 2019)
Director Corporate International Regulatory Affairs @ (May 2015 - August 2016)
Director, Global Regulatory Compliance and Govt. Affairs @ (June 2012 - August 2016)
Global Director, Regulatory Compliance @ (June 2010 - June 2012)
Director QS Compliance @ (September 1999 - June 2010)
Quality Manager @ Wilson Cook Medical (January 1991 - January 1998)
Sr. Quality Engineer @ Argon Medical (January 1985 - January 1991)
Tim Bright Education
University of California, Davis
St. Petersburg College
Tim Bright Skills
21 CFR
21 CFR Part 11
Biocompatibility
Biomedical Engineering
CAPA
CE marking
Change Control
Corrective and Preventive Action (CAPA)
Cross-functional Team Leadership
DMAIC
Design Control
Design of Experiments
FDA
FDA GMP
FMEA
Failure Mode and Effects Analysis (FMEA)
GMP
ISO
ISO 13485
ISO 14971
ISO Standards
Lean Manufacturing
Manufacturing Engineering
Medical Device Directive
Medical Devices
Orthopedic
Orthopedics
PMA
Quality Assurance
Quality Auditing
Quality Control
Quality Management
Quality System
R&D
Regulatory Affairs
Root Cause Analysis
Six Sigma
Software Documentation
Sop
Supplier Quality
U.S. Food and Drug Administration (FDA)
V&V
Validation
Verification and Validation (V&V)
Cross Functional Team
Verification And Validation V&V
Corrective And Preventive Action Capa
Cross Functional Team Leadership
Manufacturing
U.S. Food And Drug Administration Fda
Failure Mode And Effects Analysis Fmea
Endoscopy
u.s. Food and Drug Administration
Failure Mode and Effects Analysis
Corrective and Preventive Action
Verification and Validation
Tim Bright Summary
Tim Bright, based in Florida, United States, is currently a Vice President of Regulatory Affairs and Quality Assurance at IsoAid, L.L.C.. Tim Bright brings experience from previous roles at Echelon Biomedical Consulting, Bright Quality Solutions, IsoAid and ComplianceQuest. Tim Bright holds a University of California, Davis. With a robust skill set that includes 21 CFR, 21 CFR Part 11, Biocompatibility, Biomedical Engineering, CAPA and more. Tim Bright has 3 emails and 2 mobile phone numbers on RocketReach.
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