Stephanie Gee
About Stephanie Gee
Stephanie Gee is a Staff Quality Engineer with extensive experience in quality engineering and regulatory compliance within the medical device and IVD industry. She has held various roles at companies such as Adaptive Biotechnologies Corp. and Magnolia Medical Technologies, and has a strong educational background in Bioengineering and Biomedical Engineering.
Current Role at Magnolia Medical Technologies
Stephanie Gee currently serves as a Staff Quality Engineer at Magnolia Medical Technologies. She has been in this position since 2023. In her role, she focuses on ensuring quality standards are met within the organization, contributing to the development and maintenance of quality systems.
Previous Experience in Quality Engineering
Prior to her current role, Stephanie worked at Adaptive Biotechnologies Corp. as a Senior Product Development Quality Engineer from 2022 to 2023. She also held the position of Manager, Quality Engineering at the same company for five months in 2023. Earlier, she was a Quality Engineer in Design Assurance at SeaSpine from 2018 to 2020 and a Product Development Quality Engineer from 2020 to 2022.
Educational Background in Bioengineering
Stephanie studied Bioengineering and Biomedical Engineering at UC San Diego, where she earned her Bachelor of Science (B.S.) degree from 2015 to 2018. She also attended the University of California, Santa Cruz, for two years from 2013 to 2015, focusing on the same field. Her education has provided her with a strong foundation in engineering principles relevant to the medical device industry.
Skills and Expertise in Quality Management
Stephanie possesses expertise in clinical trial assay biomarker and LDT validation, along with CAP and CLIA compliance requirements. She is skilled in developing and maintaining risk management files and DHF documentation. Additionally, she is well-versed in regulatory standards such as 21 CFR 820, EU IVDD/IVDR, ISO 13485, and ISO 14971.
Early Career and Additional Roles
Stephanie's early career includes roles such as a Visitor Experience Specialist and Travel Counselor at Santa Monica Travel & Tourism in 2015 and 2016. She also worked as a Quality Engineer Intern at SeaSpine from 2017 to 2018 and as a Recreation Leader for the City of El Segundo from 2011 to 2014. These positions contributed to her diverse experience in customer service and quality assurance.