Michelle Paganini ,

Consultant

Michelle Paganini Associates
San Jose, CA

Michelle Paganini is a consultant working with all stages of medical device, biotech, and affiliated service/supplier firms, providing regulatory compliance support through her firm Michelle Paganini Associates. Her areas of expertise include developing and delivering customized Quality Systems Regulation and cGMP training, medical device auditing, providing interim leadership/QA support, system design/improvement, and personnel coaching, mentoring, and development for Quality Assurance staff members, including trainers. Previously, She held the position of Director of Quality for Align Technology (Invisalign braces). Ms. Paganini also worked in Quality Assurance for Metrika, Heartport, Becton Dickinson Immunocytometery Systems, and Syva, with concentrated experience in regulatory compliance training for FDA and international quality standards, and auditing. She has successfully hosted FDA, ISO, and TUV audits. Ms. Paganini is passionate about delivering regulatory compliance training that creates an understanding and appreciation of the benefits of formal quality systems, and the privilege and honor of working in the medical products industry. She is a former chairperson for the GMP West Coast Trainers. Ms. Paganini holds a degree in Quality Assurance and is a certified biomedical quality auditor.