Monica Summe

Monica Summe has a strong background in quality systems and project management. Monica began their career in 2012 as a Specialist in Project Management at CryoLife, Inc. where they managed cross-functional teams for product development and medical device projects. Monica then advanced to the role of Senior Specialist, where they were responsible for the development and maintenance of design control documentation. In 2016, Monica took on the role of Change Control Administrator at CryoLife, where they designed workflows and implemented change control processes. Monica also served as the internal subject matter expert for the change control process and managed cross-functional teams for product design and process changes. In 2018, Monica transitioned to the role of Quality System Engineer, conducting gap analyses and implementing changes to ensure compliance with quality system standards. Their most recent role was Director of Quality Systems at TissueTech, Inc. where they focused on implementing an electronic quality management system to new sites. Overall, Monica brings a wealth of experience and expertise in quality systems and project management to their work.

Monica Summe obtained a Bachelor of Arts degree in Biology from Franciscan University of Steubenville in the years 2004 to 2007. Monica also has additional certifications including Certified Tissue Banking Specialist from the American Association of Tissue Banks in October 2018, and CQA and CQE from ASQ - World Headquarters in 2017.