Cox, Diane

Title: Faculty

Department: Regulatory Science

BIOGRAPHY

Diane Cox has over 20 years of experience in medical device design, manufacturing, and post-market quality. She has led QMS development, remediation, and harmonization efforts across companies of all sizes, with expertise in Design Controls, Risk Management, Change Management, CAPA, and electronic system validation. Diane is an ASQ Certified Quality Auditor and has in-depth knowledge of FDA QSR (21 CFR 820), ISO 13485, and EU MDR, as well as global regulatory requirements. She is known for aligning compliance with business needs and driving continuous improvement.