Orpha James

Orpha James is a Principal Consultant with extensive experience in regulatory, quality, and compliance solutions for the medical device industry. Currently serving at Audits & QMS Inc. and Enhanced Compliance Inc., Orpha James specializes in EUMDR transition, technical file development, and compliance assessments. Previous roles include Lead Medical Assessor at Intertek, Medical Lead Auditor at TUV Rheinland, and Senior Supplier Quality Engineer at Medtronic, focusing on quality management systems and sterilization controls. Orpha James holds multiple advanced degrees in Plastics Engineering and Biotechnology, alongside a background in Chemistry and Education, providing a strong foundation for expertise in quality assurance and regulatory compliance within the medical device sector.