Mr. Shawn Bengtson joined the McGowan Institute in October 2001 as the Supervisor for Experimental Surgery in the Center for Preclinical Studies. In 2006, Mr. Bengtson assumed the responsibilities as the Quality Systems Manager, leading to the implementation of a Quality Systems Program supporting the Center’s Preclinical Studies. In this role, Mr. Bengtson oversees, implements, and provides QA support and guidance to investigator teams and industrial partners for exploratory and preclinical testing of Class II/Class III medical devices intended for regulatory submissions. As the McGowan Institute Director of Quality Assurance and Quality Systems, Mr. Bengtson also supports investigator interactions with the Food and Drug Administration and conducts orientation, refresher training and consultation for faculty, staff, students and industry partners in the areas of Quality System Processes and the FDA- Good Laboratory Practice Regulations.
In this role, Bengtson and team also support other Pitt Departments such as the Department of Virology, Center for Vaccine Research within Pitt’s Regional Biocontainement Laboratory and School of Dental Medicine’s Carniofacial Regenerative Medicine for establishing internal Quality Management Systems along with QA monitoring oversight and advisement. Mr. Bengtson and team also act as the lead for the Quality Assurance Core for the Michigan-Pitt-Wyss Regenerative Medicine Resource Center’s Interdisciplinary Translation Project funded by the NIH-NIDCR.
Prior to joining the University of Pittsburgh, Mr. Bengtson spent over 14 years at the National Aeronautics Space Administration (NASA), supporting efforts within NASA’s Space Life Sciences Division at Ames Research Center, Moffett Field California, and the International Spaceflight Life Science’s Programs Office. During his time at NASA, Mr. Bengtson performed as an Experiment Support Scientist, Deputy Payload Manager, and Operations Manager for both U.S.-based and international spaceflight collaborations. Mr. Bengtson also performed as Center’s Total Quality Management Program Lead--Life Sciences Flight Programs.
Mr. Bengtson is a Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP), a Lean Six Sigma Yellow Belt, and a voting member of the University of Pittsburgh’s Animal Care and Use Committee. He is also active with various external working groups focusing on the introduction of Quality System approaches such as Good Research Practices (GRP) implementation in academic environments.