Deb Switkowski

Document Control Manager @Mizuho OSI

Fremont, CA, US
EMAILS
d••••••••@mizuhosi.com
MOBILE NUMBERS
+15•••••••54

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WORK HISTORY

Sep 2016 — Present

Document Control Manager @Mizuho OSI

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Union City, CA, US

Document Control Manager for Medical Device - Specialty Surgical Tables and AccessoriesManage and Develop Document Control TeamResponsible for Part, Document, DHF, Training Matrix ManagementProject Leader for PLM/ERP implementationAcquired technology Document ImplementationOther Cross-Functional Projects

EDUCATION

1976 — 1978

De Anza College

Business

SKILLS

Computer System ValidationChange ManagementMicrosoft OfficeWordWritingTeam BuildingManagementMentoringResearch and Development (R&D)Process ImprovementComplianceQuality ControlGmpQuality AssuranceRegulatory AffairsSix SigmaGxpQuality AuditingTrainingIsoSopFdaCross-Functional Team LeadershipIso 14971Auditing21 Cfr Part 11Project PlanningMicrosoft WordDocumentationIso 13485Software DocumentationCgmpLean ManufacturingStart-UpsQuality SystemQuality SystemsV&VManufacturingMedical DevicesDocument Management

ABOUT DEB SWITKOWSKI

Document Control Manager with successful career in startup and large company environments. Expert qualifications in planning, organizing and using creativity to implement new, or enhance existing Document Control systems.Specialties: • 25 years Document Control experience• 25 years Supervisory / Management• SAP PLM implementation team leader• cLEAN training and implementation • Excellent training skills• Document Control system conversion• Design and implement startup systems• Excellent word processing and technical editing skills

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