Ankur Sharma

Auditor Assessor for En Iso 13485, Mdsap, Ce Mark -mdd Eu-mdr & Technical File Reviewer @DQS

Gurugram, HR, IN
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Oct 2022 — Present

Auditor Assessor for En Iso 13485, Mdsap, Ce Mark -mdd Eu-mdr & Technical File Reviewer @DQS

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IN

EDUCATION

1990 — 1992

GIC, Mathura

Senior Secondary, Bio group

2012 — 2014

Sikkim Manipal University

MBA (Total Quality Management), TQM

1990 — 1990

GIC, Mathura

Matriculation, Science Group

N/A

BSA Degree college Mathura

Bachelor of Science - BS, Chemistry

1992 — 1995

B.S.A. Degree College Mathura

B.SC, Science Bio Group

SKILLS

Method ValidationCorrective and Preventive Action (Capa)Pms/PmcfEto SterilizationProcess ValidationIsoSopFdaTqmIso 14971SterilizationRegulatory AffairsIso 13485Medical DevicesCapaClean Room ValidationAuditingMedical WritingFda GmpGxpQuality AssuranceQuality AuditingCe Certification for Medical DevicesClean RoomsInternal AuditStentsIso StandardsMedical Device DirectiveDesign DossierCe MarkingTechnical Master FileClinical EvaluationQuality SystemDrug Eluting Stents5sValidationStandard Operating Procedure (Sop)Clean Room

ABOUT ANKUR SHARMA

Senior Medical Devices Quality & Regulatory professional with 26+ years of…

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