Diane Cox is a Quality Management System (QMS) Consultant who brings over 16 years of experience in the life sciences industry, primarily in Medical Device design and manufacturing. She has a proven background of achieving quality excellence through scoping, chartering, planning, and leading cross-functional team projects, meeting business deadlines, and anticipating and mitigating project risks.
Diane has led and participated in QMS development, remediation, and integration/ harmonization efforts for medical device companies ranging in size from small to large with domestic and global presence. She has extensive experience with remediation of QMS processes and records resulting from FDA 483’s and Warning Letters. She specializes in post-market quality processes, and she served as a subject matter expert for CAPA and Field Actions throughout her Corporate career. She also has participated in the validation of software systems to streamline quality processes for electronic management.
With an ASQ Certified Quality Auditor designation, Diane has conducted a number of supplier qualification audits and internal audits. She has completed formal training to the US FDA’s Quality System Regulation (21 CFR 820), ISO 13485:2016, and the European Union’s Medical Device Regulation (EU MDR), and has working knowledge of Health Canada Brazil ANVISA, Australia TGA, and Japan MHLW medical device requirements. She has actively participated in Risk Management Activities in accordance with ISO 14971:2019.
Diane is skilled in finding an effective balance between meeting the needs of the business and meeting regulatory requirements, and she upholds continuous improvement concepts to ensure processes evolve with changing regulations, standards, and company growth.