Bob Burdge
Senior Quality & Regulatory Consultant @Bioteknica, An Iqvia Business
Madison, WI, US
EMAILS
MOBILE NUMBERS
+14•••••••72
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WORK HISTORY
Apr 2018 — Present
Senior Quality & Regulatory Consultant @Bioteknica, An Iqvia Business
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EDUCATION
1969 — 1974
Brigham Young University
BS, Microbiology
SKILLS
Iso 13485Quality ControlGmpContract ManufacturingMedical Device DirectiveCqaQuality ManagementSterilizationRegulatory AffairsIsoSopFdaSpcContinuous Improvement21 CfrSix SigmaQuality Auditing21 Cfr Part 11Quality SystemV&VProcess SimulationRoot Cause AnalysisR&DLean ManufacturingComputer System ValidationMedical DevicesCapaIso 9000DmaicRegulatory SubmissionsDesign ControlFmeaFda GmpBiotechnologyCe MarkingProcess ImprovementCross-Functional Team LeadershipValidationSupplier QualityIso 14971
ABOUT BOB BURDGE
Director, QA/RA at Natus Medical Incorporated
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