Agnes Terenyi

Director of Quality Management Systems @OVERJET

Walnut Creek, CA, US
EMAILS
a••••@overjet.ai
MOBILE NUMBERS
+13•••••••16

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WORK HISTORY

Mar 2026 — Present

Director of Quality Management Systems @OVERJET

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Established from the ground up and currently managing the company’s Quality Management System (QMS). Relying on the ISO 13485:2016 standard, regulations of the MDSAP regions and the EU MDR 2017/745, I strive for maintaining efficient and compliant QMS processes.I routinely support AI-powered software-as-a-medical device design & development activities, as well as regulatory submissions on the US- and international markets.I host and support all QMS audits and maintain a close partnership and communication with our external supporting organizations (Notified Body, Auditing Organization, Australian Sponsor, etc.)

EDUCATION

2006 — 2010

Budapest University of Technology and Economics

Bachelor of Science (BSc), Environmental Engineering

2011 — 2012

Washington University in St. Louis

Master of Science (MS), Energy, Environmental and Chemical Engineering

SKILLS

AnalysisIso 13485Uv/VisStatisticsAnalytical SkillsProject ManagementLean ThinkingQuality AssuranceMicrosoft OfficeManufacturingLaboratory SkillsMicrosoft ExcelMicrosoft Office Sharepoint ServerCgmp ManufacturingAutocadUv-Vis SpectrophotometerChemical EngineeringEnvironmental EngineeringData AnalysisChemistryLaboratoryMatlabPpiResearchVisioIcp-MsSharepoint DesignerTechnical WritingEngineeringIso 9001Quality ControlSonication

ABOUT AGNES TERENYI

I am a seasoned Quality Systems professional, passionate about helping organizations thrive by implementing efficient and compliant quality management processes and championing continuous improvement.

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Agnes Terenyi — Email, Phone Number & Contact Info | Unifers