Exceptional auditor and creator of quality systems that meet and exceed ISO 9001 and ISO 13485 standards including adherence to FDA guidelines. Has over 20 years of leadership, management, and Quality System experience in a variety of fields. Combines real world manufacturing and regulation requirements to ensure that Quality System not only meets requirements but also works for your companies individual needs.
Provide comprehensive review or development of Quality System that complies with ISO 9001 and/or ISO 13485 standards. Certified Business Improvement Lead Auditor by RAB/QSA, as well as CQE by ASQ. Also have experience with FDA audits, QSIT, CE designation, MDR etc.
Masters of Business Administration
U.S. Naval Academy
Bachelor of Science