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Brad Andersen Location
Minneapolis, MN, US
Brad Andersen Work
VP Operations and Quality @ (November 2016 - Present)
Director QE @ (July 2013 - November 2016)
Director of Quality @ Lutonix, Inc. (August 2008 - May 2013)
Director QA and RA @ Restore Medical (January 2005 - January 2008)
Director QA and RA @ (November 2000 - March 2005)
Quality Systems Eng. Manager @ Pharmacia / SIMS Deltec (January 1987 - January 2000)
Manager Quality Assurance @ Smiths Medical (Deltec) (January 1984 - January 2000)
Brad Andersen Education
University of Minnesota
BS (Microbiology)
1978-1984
Brad Andersen Skills
ISO13485
FDA GMP
Vendor Management
Validation
Verification
Sterilization
Biocompatibility
Supplier Quality
Regulatory Affairs
R&D
Design of Experiments
Biotechnology
Manufacturing
Cross-functional Team Leadership
Product Launch
Biomedical Engineering
Quality Auditing
Sop
Product Development
GLP
Lifesciences
Quality System
ISO 13485
Medical Devices
V&V
GMP
Quality Assurance
FDA
ISO 14971
21 CFR
PMA
21 CFR Part 11
U.S. Food and Drug Administration (FDA)
Cross Functional Team
Business Analysis
Engineering
Strategic Planning
Microsoft Office
Cross Functional Team Leadership
U.S. Food And Drug Administration Fda
Leadership
Management
Marketing
Microsoft Excel
Java
u.s. Food and Drug Administration
Brad Andersen Summary
Brad Andersen, based in Minneapolis, MN, US, is currently a VP Operations and Quality at Urotronic, Inc.. Brad Andersen brings experience from previous roles at St. Jude Medical, Lutonix, Inc., Restore Medical and Vascular Solutions. Brad Andersen holds a 1978 - 1984 BS in Microbiology @ University of Minnesota. With a robust skill set that includes ISO13485, FDA GMP, Vendor Management, Validation, Verification and more. Brad Andersen has 2 emails and 1 mobile phone numbers on RocketReach.
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