Paul Mayon

About Paul Mayon

A highly motivated and strategically focused leader who gets things done. A proven track record of servant leadership to lead people across a broad range of regulatory, quality and transformational disciplines. Proven ability to deliver KPI outputs on time, on budget and to specification to effectively run a P&L. Expert in global medical device regulation, quality and critical thinking skills to transform a business. Data driven to create solutions and optimize outputs. High level communication and collaboration skills. Ensures successful socialization of initiatives. Strong networking capability in matrix organizations from delivery to C-Suite level to form consensus-based decisions.

Experience

1. Director, Quality Assurance

   OrganOx

   Apr 2025 — Present · NJ, US

   Oversight of quality assurance efforts in support of our Quality Management and Oversight (Auditing and KPI Monitoring) Systems, reflecting Organox core values of innovation, evidence, integrity, teamwork, respect, and a commitment to transplantation. Responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures, training materials, and controls enhancing the performance and quality of products and the company capability to demonstrate conformance to established standards and agency regulations.

Education

• The Open University

  Bachelor of Engineering (BEng), Mechanical Engineering

  2000 — 2006

• Lancaster University

  Post Graduate Certificate of Education, Education and Teaching

  1993 — 1994

• The University of Salford

  Bachelor of Arts (BA), Music, Music Synthesis and Recording Techniques

  1985 — 1988

• The Open University

  Master of Engineering, Mechanical Engineering

  2010 — 2012

Skills

• Astm Standards
• Mechanical Testing
• Product Development
• Biomechanics
• Product Launch
• Design Control
• Fmeca
• System Verification
• Regulatory Requirements
• Medical Device Directive
• Orthopedics
• Fda
• Technical Documentation
• Project Planning
• Technical Presentations
• Root Cause Analysis
• Management
• Ms Project
• Technical Analysis
• Project Management
• Technical Leadership
• Iso 13485
• Biomedical Engineering
• Product Validation & Verification
• Technical Writing
• Mechanical Engineering
• Technical Support
• Team Management
• Medical Devices
• Capa
• Regulatory Submissions
• Failure Analysis
• Standards Development
• Standards Compliance
• Pmda
• Risk Assessment
• Fmea
• Quality System
• Finite Element Analysis
• Validation