Leonora Felon

About Leonora Felon

Highly competent leader committed to cross functional product development to ensure quality product as well as customer satisfaction and regulatory compliance with overall cost in mind. Experienced in product development from concept to commercialization with both instruments and implants. Knowledgeable in development of design verification and validation testing and reports. Experience with design transfer to manufacturing including gage creation, inspection based on design and first article inspections. Background in root cause investigations, customer complaint investigations and corrective action processes. Facilitates resolution to supplier and customer issues with diplomacy and builds long-standing relationships. Skilled in MS Project and MS Office suite.Experienced Product Development and Quality Engineer with demonstrated history of working in the medical device industry. Skilled in Geometric Dimensioning & Tolerancing, AutoCAD, Design Control, Product Design, Regulatory Compliance and Medical Devices. Strong engineering professional with a Master of Science in Bioengineering from the University of Toledo with specialization in biomechanics and noted as an Engineer Intern by the state of Ohio.

Experience

1. Senior Quality Engineer Ii

   Zimmer Biomet

   Jul 2018 — Present · Warsaw, IN, US

   Patient Matched Implants (PMI): Nov 2020- PresentCreated Risk Management Files for Custom devicesCreated inspection plans for Custom devicesHandled HHEs, NCRs, PHs, IEs, etc. Independent Reviewer for PMI casesTrauma/Lower Ext/SET: July 2018- Oct 2020Business Unit Quality Lead for Remediation projects Managed remediation team contractorsHandled HHEs, NCRs, PH Created multiple DHFs and RMFsParticipated in Audits; front room, back room and responsesIndependent Reviewer for Customs group within PMI/SSI team

Education

• The University of Toledo

  MS, Bioengineering

  2005 — 2010

• The University of Toledo

  BS, Bioengineering

  2000 — 2005

Skills

• Corrective and Preventive Action (Capa)
• Orthopedics
• Quality Assurance
• Fda
• Spine
• Communication
• Problem Solving
• Iso 13485
• Biomaterials
• Medical Devices
• Validation
• Biomedical Engineering
• Quality System
• R&D
• Testing
• Orthopedic
• Solidworks
• Product Development
• Biomechanics
• Design Control