Michael Ledee
Director of Qa @Karius
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WORK HISTORY
Director of Qa @Karius
US
EDUCATION
University of California, Davis
BS, Chemistry
SKILLS
ABOUT MICHAEL LEDEE
A senior business leader with extensive global quality management, regulatory compliance and comprehensive business skills and experience. Extensive experience in the medical device, clinical, IVD, pharmaceutical and food safety industries. Led many successful global business projects, primarily in quality management, product realization and process improvement areas. Able to establish rapport and creditability with both internal and external functional groups. Effective global leader who builds strong organizations and drives substantial operating improvements. Solution-oriented with an eye toward customer focus and bottom-line results. Keen knowledge in the following areasISO-13485/900121 CFR 820 ISO-9001Quality Planning Supplier ManagementRisk Management Customer ServiceDistribution ServiceStrategic Planning Validation Audits/Inspections CAPACompliance/RegulatoryIVDRKaizen Operations MDSAPFMEAIVDRIVDCompanion DiagnosticsCompliance/RegulatoryDesign Control 510k/PMAProject ManagementHazard AnalysisGxP/GCP/GLP
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