James D. Werner

About the Expert

Jim, Principle Consultant MDQC – Medical Device Quality Compliance, LLC is a seasoned professional in the medical device industry with extensive expertise in quality assurance and regulatory compliance.  Responsibilities have ranged from local plant quality management to directing multi-plant, international, corporate quality and compliance operations. During his 35+ years of experience he has acquired a solid background in FDA regulations, ISO 13485, and related standards and regulations.  He has demonstrated the ability to implement and enhance quality systems for medical device manufacturers and their suppliers.  Jim is a senior member of the American Society for Quality (ASQ), serves on their “Ask the Expert” panel, and is a voting member of the U.S. TAG 176 for international quality standards.  He is a graduate of Rutgers University, a Certified Quality Engineer, Certified Quality Auditor, and past RAB Certified Lead Auditor for ISO.  Jim served honorably in the U.S. Air Force.