Tatiana Shmeleva
Global Post Market Surveillance Program Director @Philips
Boston, MA, US
EMAILS
MOBILE NUMBERS
+91 *********19
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WORK HISTORY
Feb 2022 — Present
Global Post Market Surveillance Program Director @Philips
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SKILLS
Quality SystemsContinuous ImprovementAccount ManagementProcess ImprovementSoftware DocumentationProject ManagementGmpCapaTechnical WritingDesign ControlMedical DevicesRegulatory AffairsDocumentationIso 13485ValidationSoftware Quality21 CfrQuality ControlSopMs ProjectQuality SystemComputer System ValidationInternal AuditRegulatory RequirementsTest MethodologiesQuality EngineeringTest PlanningSoftware ValidationSoftware Quality AssuranceComplianceU.s. Title 21 Cfr Part 11 RegulationTestingQuality AssuranceBiotechnologyQuality ManagementSix SigmaChange ControlUser Acceptance TestingQuality AuditingGap Analysis
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