James Shore is the Chief Quality Officer at Quality Lean Solutions, a veteran-owned consultancy supporting medical device and regulated industries. He has more than 30 years of experience in quality systems, auditing, and regulatory compliance, including FDA and ISO 13485 environments. Shore is an ASQ-certified Six Sigma Black Belt, Medical Device Auditor, Quality Manager/Operational Excellence, Quality Auditor, and Quality Inspector, and regularly teaches and speaks on practical, risk-based approaches to quality and compliance.
