Director Of Quality Assurance@ BioTeknica Engineering & Regulatory Services
Madison, Wisconsin, United States
Bob Burdge
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Brigham Young University
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FlashIntel GPTBob Burdge is a highly experienced professional with 49.4 years of work experience in the field of quality systems and assurance. He has expertise in medical devices, ISO 13485, FDA regulations, and quality management. Bob has held various leadership positions at Natus Medical Incorporated, including Senior Quality and Regulatory Consultant and Director of QA/RA. He has also worked at CareFusion and Cardinal Health, gaining valuable experience in research and analytics. Bob's strong background in regulatory affairs and continuous improvement makes him a valuable asset in the industry.
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About
Director, QA/RA at Natus Medical Incorporated
Work Experience
Director Of Quality Assurance
Senior Quality And Regulatory Consultant
Medical Equipment Manufacturing
Bob Burdge's Professional Milestones
- Manager Quality Systems (1997-01-01~2000-01-01): Implementing a seamless quality control system to achieve precise and timely delivery of products.
- Director Of Quality Assurance (2007-10-01~2009-10-01): Streamlining quality control processes to ensure high-quality products and processes.
Education
Microbiology,
Bachelors,
Bachelor Of Science
1969-1974Skill
Quality System
Quality Assurance
Medical Devices
Iso 13485
Fda
Capa
Quality Management
Design Control
Cross Functional Team Leadership
Iso 14971
Medical Device Directive
V&v
Process Improvement
Validation
Six Sigma
Change Control
Sterilization
Regulatory Affairs
Gmp
Quality Auditing
Continuous Improvement
R&d
Lean Manufacturing
Root Cause Analysis
Fda Gmp
Dmaic
Ce Marking
21 Cfr
21 Cfr Part 11
Iso
Supplier Quality
Iso 9000
Biotechnology
Process Simulation
Quality Control
Fmea
Regulatory Requirements
Cqa
Sop
Regulatory Submissions
Spc
Computer System Validation
Contract Manufacturing
Certification
Colleagues
Steve Maltz
Marketing And Sales Director
Mary Suarez
Validation Assignments Manager
Brian Dawson
sr quality consultant & regulatory compliance project manager at bioteknica inc
Magda Nino
Resource Planning Assistant | Allocation Manager Assistant
Jorge Rodriguez
principal bioteknica
Other Named Bob Burdge
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Bob Burdge works for BioTeknica Engineering & Regulatory Services
Bob Burdge's role in BioTeknica Engineering & Regulatory Services is Director Of Quality Assurance
Bob Burdge works in the industry of Medical Equipment Manufacturing
Bob Burdge's colleagues are Steve Maltz,Mary Suarez,Brian Dawson
Bob Burdge's latest job experience is Director Of Quality Assurance at BioTeknica Engineering & Regulatory Services
Bob Burdge's latest education in Brigham Young University
