Ana Hernandez

Senior Quality Assurance Specialist @Route 92 Medical

Hayward, CA, US
MOBILE NUMBERS
+14•••••••49

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WORK HISTORY

May 2022 — Present

Senior Quality Assurance Specialist @Route 92 Medical

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San Mateo County, CA, US

EDUCATION

1995 — 1997

San Jose City College

no, English,Matemathics

SKILLS

Quality SystemV&VMinitabQuality AuditingStatistical Process Control (Spc)Quality ManagementIsoSopIso 13485FdaCe MarkingResearch and Development (R&D)InspectionCorrective and Preventive Action (Capa)DmaicChange ControlManufacturing EngineeringSolidworksDesign ControlProduct DevelopmentCathetersLean ManufacturingFmeaBiomedical EngineeringCalibrationSupplier QualityIso 14971Software DocumentationQuality AssuranceDesign for ManufacturingRoot Cause AnalysisBiocompatibilityQuality ControlGmpInjection MoldingSpc21 Cfr Part 11R&DValidationSterilization

ABOUT ANA HERNANDEZ

Extensive experience in quality assurance inspection for a wide range of medical device technologies. Processing DCO\'s for Document Control and for manufacturing. Fully trained and familiar with GMP, ISO 13485 regulations and Class manufacturing environment. Passionate about quality and customer satisfaction. Outstanding skills with inspection instrumentation, documentation and techniques. High attention to detail, articulate and diligent.Specialties: Medical.Devices

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