Michelle Paganini, CPIM, CQA

Ms. Paganini knows medical device systems from a broad based perspective.

Starting her career in manufacturing, Michelle has moved up through the medical device industry
with experience within a production lab, in production control as a planner, and as a master
scheduler prior to her focus in quality assurance.

Her employment positions have included:
- Director of Quality for Align Technology, manufacturer of Invisalign braces.
- Manager of Quality, Metrika
- Various positions for Heartport, Becton Dickinson Immunocytometry Systems, Syva Co.


Ms. Paganini has also handled consulting projects for:
- Rubicor Medical
- Chiron Corporation
- BD Biosciences
- Microgenics
- Biosite
- Align Technology
- Menlo Care

Michelle has a degree in Quality Assurance and she is a Certified
Biomendical Quality Auditor.

Michelle is a sought-after speaker and has presented at important industry
events since 1993, including: Good Manufacturing Practices (GMP) West Coast
Trainers meetings, GMP Training and Education Association (TEA) meeting,
an International Society of Pharmaceutical Engineers (ISPE) meeting,
American Society for Quality (ASQ) Biomedical conferences, and repeatedly
as a guest faculty member for Stanford University's Biodesign Innovation Program.

She is widely recognized as a dynamic trainer, with an ability to bring excitement to
regulatory training topics.

Michelle has also contributed to the book, "Biodesign: The Process of Innovating Medical Technologies", published in 2010, by authors Stefanos Zenios, Josh Makower, Paul Yock, Todd J. Brinton, Uday N. Kumar, Lyn Denend, and Thomas M. Krummel.

 CLICK HERE for Michelle's Resume

In her free time, Michelle is also an accomplished fine artist. Click here to see some of her work!

Personal note: Prior to June 2000, Michelle Paganini was known as Michelle Babcock.