Bob Burdge Email & Phone Number
Senior Quality and Regulatory Consultant @ BioTeknica Engineering & Regulatory Services
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Bob Burdge Location
- Madison, WI, US
Bob Burdge Work
- 2018 -now Senior Quality and Regulatory Consultant @
- 2013 -2018 Senior Director, QA and RA @ Natus Medical Incorporated
- 2009 -2012 Director, QRA NeuroCare @ CareFusion
- 2007 -2009 Director QRA @
- 2002 -2007 Global Quality Manager @
- 2000 -2002 Director, Quality Assurance @ Pharmanetics
- 1997 -2000 Manager, Quality Services @ Andrew Jergens
- 1997 -2000 Manager, Quality Systems @
- 1984 -1997 Quality Manager @
- 1976 -1984 Lab Manager, Quality Assurance @
- 1974 -1976 Medical Technologist @ Jersey Shore Medical Center
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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