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Sarah Payne
Director, Design Assurance, Senior Manager, Design Assurance @AtriCure, Inc.
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WORK HISTORY
Director, Design Assurance, Senior Manager, Design Assurance @AtriCure, Inc.
Mason, OH, US
Leading a team of Quality Engineers to ensure safety, reliability, and QMS compliance of AtriCure\'s globally-distributed innovative medical devices used to treat Afib and improve patients\' lives.Partner with cross functional peers to prioritize and staff comprehensive project list. Identify and delegate/execute optimization of design control processes to maximize efficiencies and drive continuous improvement activities as needed.Managed and led three cross-functional teams simultaneously through gap assessment, Design History File (DHF) remediation, and EU MDR submission compilation activities for four families of Class II and Class medical devices.Led and executed systemic updates for all AtriCure medical device risk management files (Risk Management Plans and Reports, FMEAS) to achieve ISO 14971:2019 and EU MDR compliance.
SKILLS
ABOUT SARAH PAYNE
Reliable leader with 15 years of quality-driven experience in new product development and…
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