2011 -
2015 VP, Quality Assurance and Regulatory Affairs @
2006 -
2011 VP Quality Assurance @
2003 -
2011 Vice President, Quality Assurance @
2006 -
2011 Global VP, Quality Assurance @ Covidien Respiratory and Monitoring Solutions
Mike Spears Education
Darla Moore School of Business at the University of South Carolina
MBA (Business)
1995
-
1998
University of Tennessee, Knoxville
BA
1982
-
1987
Mike Spears Skills
Design Control
Quality Assurance
ISO 13485
FDA
Regulatory Affairs
Medical Devices
Validation
GMP
CAPA
Cross-functional Team Leadership
Quality System
ISO 14971
V&V
DMAIC
Root Cause Analysis
Six Sigma
Leadership
21 CFR Part 11
R&D
Corrective and Preventive Action Capa
Microsoft Excel
Public Speaking
Pharmaceutical Industry
Verification and Validation V&V
Cross Functional Team Leadership
Research and Development R&d
u.s. Food and Drug Administration Fda
u.s. Food and Drug Administration
Corrective and Preventive Action
Verification and Validation
Research and Development
Mike Spears Summary
Mike Spears, based in United States, is currently a Senior Vice President, Regulatory Affairs and Quality Assurance at Solventum. Mike Spears brings experience from previous roles at 3M, Insulet Corporation and Covidien. Mike Spears holds a 1995 - 1998 MBA in Business @ Darla Moore School of Business at the University of South Carolina. With a robust skill set that includes Design Control, Quality Assurance, ISO 13485, FDA, Regulatory Affairs and more. Mike Spears has 2 emails and 1 mobile phone numbers on RocketReach.
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