Jim Craig - Senior Consultant, Quality Assurance

Jim is a Certified Lead Auditor with a long history in the highly regulated, quality-control-conscious aerospace and defense industries. Since 2000, Jim has applied his extensive experience in QMS development and auditing to the medical device industry. He specializes in helped companies develop effective quality management systems that are in full compliance with US, European and Canadian requirements. Documentation development, traceability, internal auditing, Corrective and Preventive Action (CAPA), SOP development and other QA issues are all areas in which Jim has very specific expertise.

Because Jim has worked with so many medical device companies making a wide variety of products, he knows how to tailor quality management solutions to fit the specific needs of the clients he represents, and simplify the quality requirements while maintaining regulatory compliance.