Marvin Sringkarawat

Regulatory Specialist for Medical Devices @FDA

San Diego, CA, US
MOBILE NUMBERS
+18•••••••53

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WORK HISTORY

Jul 2024 — Present

Regulatory Specialist for Medical Devices @FDA

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EDUCATION

1996 — 2000

DeVry University

BSEET, Bachelor of Science Electrical Engineering Technology

SKILLS

InspectionU.s. Food and Drug Administration (Fda)ManufacturingIso 14971IecTestingFmeaQuality ControlContinuous ImprovementCalibrationQuality AssuranceQuality ManagementElectronicsSix SigmaSoftware DocumentationElectromagnetic CompatibilityRoot Cause AnalysisIso StandardsMedical DevicesCapaIso 9000Process ImprovementCe MarkingValidationIso 13485Iec 60601Design ControlQuality SystemProduct SafetyElectriciansRfIsoBusiness Process ImprovementFdaProduct CertificationUlIso 17025

ABOUT MARVIN SRINGKARAWAT

15 years of success in Quality/Compliance Engineering and product investigations. Provide compliance/quality engineering expertise for improving product design and manufacturing processes. Well versed in product application and functionalities, quality management systems, principles, and methodologies of quality system regulations and ISO standards. Expertise in performing root-cause analysis, testing life cycle, product verification processes and process improvement techniques. Excellent understanding of the regulatory requirements that govern development of medical and non-medical products as well as their use in health care environments.

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