Sarah Payne

About Sarah Payne

Reliable leader with 15 years of quality-driven experience in new product development and…

Experience

1. Director, Design Assurance, Senior Manager, Design Assurance

   AtriCure, Inc.

   Jun 2019 — Present · 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

• Quality Control
• Powder X-Ray Diffraction
• Quality Assurance
• Iso 13485
• Medical Devices
• Corrective and Preventive Action (Capa)
• Dmaic
• Automotive
• Six Sigma
• Materials Science
• Failure Analysis
• 21 Cfr Part 820
• Iso/Ts 16949
• R&D
• Characterization
• Research
• Spectroscopy
• Metallurgy
• Engineering
• Design of Experiments
• Manufacturing
• Microsoft Office
• Advanced Product Quality Planning (Apqp)
• Afm
• Supplier Quality
• Nanotechnology
• Production Part Approval Process (Ppap)
• Optical Microscopy
• Scanning Electron Microscopy