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Bob Burdge Location
Madison, WI, US
Bob Burdge Work
Senior Quality and Regulatory Consultant @ (April 2018 - Present)
Senior Director, QA and RA @ Natus Medical Incorporated (May 2013 - March 2018)
Director, QRA NeuroCare @ CareFusion (September 2009 - July 2012)
Director QRA @ (October 2007 - October 2009)
Global Quality Manager @ (January 2002 - January 2007)
Director, Quality Assurance @ Pharmanetics (January 2000 - January 2002)
Manager, Quality Services @ Andrew Jergens (January 1997 - January 2000)
Manager, Quality Systems @ (January 1997 - January 2000)
Quality Manager @ (January 1984 - January 1997)
Lab Manager, Quality Assurance @ (February 1976 - July 1984)
Medical Technologist @ Jersey Shore Medical Center (June 1974 - February 1976)
Bob Burdge Education
Brigham Young University
BS (Microbiology)
1969-1974
Wall Township High
Bob Burdge Skills
FDA
ISO 13485
CAPA
Quality System
Medical Devices
Design Control
V&V
ISO 14971
Validation
Quality Assurance
CQA
GMP
Quality Management
Six Sigma
Regulatory Affairs
CE marking
Quality Auditing
Root Cause Analysis
Continuous Improvement
21 CFR
Process Improvement
Biotechnology
Sop
Change Control
ISO
R&D
Lean Manufacturing
Process Simulation
21 CFR Part 11
Supplier Quality
FDA GMP
Regulatory Submissions
Quality Control
Cross-functional Team Leadership
SPC
FMEA
Computer System Validation
Regulatory Requirements
Contract Manufacturing
DMAIC
Iso 9000
Medical Device Directive
Sterilization
Customer Service
Strategic Planning
Design
Cross Functional Team Leadership
Project Management
Business Analysis
Microsoft Excel
Strategy
Bob Burdge Summary
Bob Burdge, based in Madison, WI, US, is currently a Senior Quality and Regulatory Consultant at BioTeknica Engineering & Regulatory Services. Bob Burdge brings experience from previous roles at Natus Medical Incorporated, CareFusion, Cardinal Health and GE Healthcare. Bob Burdge holds a 1969 - 1974 BS in Microbiology @ Brigham Young University. With a robust skill set that includes FDA, ISO 13485, CAPA, Quality System, Medical Devices and more. Bob Burdge has 2 emails and 3 mobile phone numbers on RocketReach.
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