Shawnna W.

Quality Systems Supervisor @AtriCure, Inc.

Cincinnati, OH, US
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Dec 2021 — Present

Quality Systems Supervisor @AtriCure, Inc.

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Mason, OH, US

Compliance Management of Quality Management System with domestic and international medical device quality regulations.• Led and coordinated team of Quality Coordinators, providing guidance on daily operations, projects, decision making and end user support.• Developed state-of-the-art solutions for the Quality Management System to enhance efficiency.• Maintained quality systems records in line with regulatory standards.• Served as SME for internal and external audits.• Management of uploading new/revised IFU’s for Global use to external facing company website•Tracking, Trending and Reporting of QMS Metrics• Inventory management for all offsite Record Storage

EDUCATION

2017 — 2017

Xavier University

Project Manager Certification Program

N/A

University of Cincinnati

Biology

N/A

Southern State Community College

Associate of Arts and Sciences (A.A.S.)

SKILLS

Technology TransferValidationCleaning ValidationHplcGmpGampBiopharmaceuticalsEnvironmental MonitoringComputer System ValidationRoot Cause AnalysisCell Culture21 Cfr Part 11CipDeviationsClean RoomsCgmp ManufacturingAnalytical ChemistryBatch RecordsGxpQuality AuditingAseptic ProcessingLyophilizationSterilizationRegulatory AffairsLifesciencesAutoclavePharmaceutical ManufacturingQuality SystemV&VFda GmpSop DevelopmentLimsLalGlpUspBioburdenAseptic TechniqueMicrobiologyPharmaceutical IndustrySop

ABOUT SHAWNNA W.

As a Quality Systems Supervisor at AtriCure, Inc, I leverage my expertise in quality…

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Shawnna W. — Quality Systems Supervisor at AtriCure, Inc. in Cincinnati, OH, US | Unifers