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Barry Mirrer

Head of Quality Assurance @PROMETRIKA, LLC

Cambridge, MA, US
EMAILS
[email protected]
MOBILE NUMBERS
+91 *********19

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WORK HISTORY

Jul 2019 — Present

Head of Quality Assurance @PROMETRIKA, LLC

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Cambridge, MA

EDUCATION

N/A

Massachusetts Institute of Technology

SB; SM

SKILLS

Process ImprovementU.s. Title 21 Cfr Part 11 RegulationGcpCareer DevelopmentU.s. Food and Drug Administration (Fda)AuditingSdlcSoftware DocumentationInnovative Problem SolverSoftware MaintenanceTestingBusiness Process ImprovementIso 9001Quality ManagementSoftware Quality AssuranceDocument Management21 Cfr Part 11Process DevelopmentIso 13485Change ManagementCapaClinical TrialsProduct ManagementQuality AuditingQuality AssuranceManagementComputer System ValidationFdaQuality SystemValidationSoftware DevelopmentIsoCross-Functional Team LeadershipSopMentoringQuality Systems

ABOUT BARRY MIRRER

MIT-educated technology and quality professional with proven experience building teams, defining processes, fixing problems and making things work. • Builds trust with key stakeholders to generate results and achieve goals • Quick study with broad technical knowledge and experience using creative methods and tools to solve problems and design permanent solutions • Developed new departments and expanded existing departments at several companies; grew and mentored managers and individual contributors • Strong GCP (Good Clinical Practice) experience, including Late Phase Research and Real-World Evidence • Drives results while maintaining positive employee morale and engagement • Quality system experience includes GxP, ISO 9001, FDA 21 CFR Part 11, CMM • Defined, managed and rolled out multiple technical and process systems. • Champion of Quality in the organization; Fosters a Quality mindset in others • Cross-industry experience includes healthcare, software validation, wide-area and PC networking, multi-computing, fiber-optics manufacturing, semiconductor testing

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