Tracy Mattson

Principal Advisor

Tracy’s QLeaR Advantage

My Why:  I began my career as an analytical chemist in pharmaceutical and medical device laboratories.  I quickly discovered I had a knack for technical writing, understanding regulatory requirements, and improving quality systems.  After eight years, I left the laboratory and began working full-time in Quality Assurance and Engineering for the biotechnology and medical device industries; working in Quality checks all of my boxes.  I get to work closely with engineering to understand the science and technical requirements of components, products, and processes.  I get to audit and improve quality systems.  I get to work on quality investigations and solve problems.   And I get to write, write, write all about it.        

My Favorite Project: I achieved my Master’s in Education at the University of Minnesota while working in a pharmaceutical company laboratory. My Master’s project involved developing a training program that included multiple functional areas and corporate sites. Ever since, I’ve been involved in developing and/or improving training programs for biotechnology and medical device companies. I enjoy working with teams to identify needs, watching processes to create meaningful training materials, and delivering training events.

Areas of Focus:  Auditing, Quality Investigations, Inspection, Training, Supplier Quality, and Technical Writing across the Pharmaceutical, Biotechnology and Medical Device Industries   

Years of experience:  32 years

Education and Certifications:  

• B.S., ACS Chemistry
• M.A., Education