John A. Traxler is a seasoned leader, mentor, coach, and trainer with a robust background spanning Quality, Industrial Engineering, Operations, and P&L management. He is dedicated to leading organizations that value integrity, creativity, and teamwork.

With deep, practical experience across diverse manufacturing environments—including Medical Device, Microelectronics, Agricultural, Construction & Mining equipment, and Steel Production—John possesses the expertise to help small to medium-sized businesses design and implement robust Quality Management Systems (QMS) and solve persistent operational challenges.

Core Qualifications for Your Business

John's qualifications are built on a track record of implementing strategic improvements and achieving measurable results:

• Designing and Implementing Quality Management Systems:

  • As a Quality Director, John was responsible for all aspects of Quality & Regulatory compliance in accordance with ISO 13485 & FDA 21CFR820. He led multi-site compliance across twelve facility locations in the US and Europe.

  • John is an AS9100, ISO 13485, and ISO 9001 Certified Lead Auditor, ensuring that systems he designs are not only compliant but built for effectiveness.

• Solving Nagging Problems through Continuous Improvement:

  • He specializes in Daily Management and developing value stream quality metrics focused on yield, using data to identify the Top 5 issues and focus on the Top 1.

  • He has a proven ability to deliver cost savings.  Projects range from $150k to $1.5mil.

  • He focuses on Quality-At-The-Source by leading teams to develop simplified standard work.

• Consulting and Risk Management:

  • John has direct experience providing Quality Management consulting to clients looking to develop ISO9001, ISO13485, and AS9100 compliant systems or obtain stand-alone ISO certification.

  • He has led organizations in analyzing risk on an ongoing basis, translating needs into a strategic plan for improvement.

John's diverse background, which includes roles as a Quality Director, Site Quality Leader/Facility Security Officer, and Department Manager in manufacturing and logistics operations, provides him with a holistic perspective. This ensures that the quality solutions he proposes are practical, compliant, and integrated seamlessly with your business operations.

John holds a Master of Business Administration (MBA) from Saint Francis University and a Bachelor of Science in Industrial Engineering from Penn State University. He is an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE).