William Ditty

William (Bill) Ditty has more than 2 decades of experience as a highly accomplished and results-oriented quality assurance executive, with extensive global expertise in strategy development and deployment, regulatory compliance, risk management, program and project management, and audits and inspections. Prior to working in the medical device industry, quality, and regulatory, Bill served as a commissioned officer in the US Coast Guard.

Bill has years of experience in FDA inspections, quality, and regulatory compliance, including creating a regulatory compliance program and implementing a mock FDA inspection program to proactively remediate issues prior to inspection. He has implemented global quality systems from the ground up (MDSAP, EU MDR, etc.), led transition and remediation projects, and has technical working knowledge of many medical device groups, including software and connected medical devices, orthopedic, neurology, ear / nose / throat, implantables, and radiology.

Bill’s experience includes:

• Quality Management Systems – Developed and led a global quality management system (US, EU, India, Asia, etc.,) and created key performance indicators with continuous improvement in all areas of quality assurance, including CAPA and complaint handling, design transfer, production and process controls, risk management, and validation.
• Auditing – Has lead auditor experience in the EU and MDSAP (US, Australia, Brazil, Canada, and Japan) regulations as well as in China, India, and beyond, with a focus on risk- and process-based auditing, internal audits, baseline and preassessments, and supplier audits.
• Training – Is a recognized expert in delivering quality and / or regulatory classroom training, as well as developing course materials and content for global training programs.
• Regulatory – Has experience with 510(k) submissions, Medicare reimbursement, and clinical trials (IDE).