Susan Chung | Sr. Director of QA & RA
Susan Chung is the Sr. Director of Quality Assurance and Regulatory Affairs at Neuronoff, Inc.
Susan has over 20 years of experience in the medical device industry. She has led QA/RA teams at several small and large companies in the Bay Area before joining Neuronoff, Inc. and has successfully balanced her large corporation experience with the mindset for small startup agility. Under her leadership, Neuronoff achieved ISO-13485:2016 certification in 2020 and MDSAP certification in 2022.
Prior to her work at Neuronoff, Susan helped several startup companies build robust Quality Management Systems (QMS) from ground zero, including one she co-founded herself. She has worked with various Regulatory Bodies to help companies obtain QMS Certificates such as ISO 9001 and 13485, CE Mark, and Medical Device Licenses. Susan has a proven track record of leading and hosting successful audits without major non-conformances. Being a certified ISO 13485 lead auditor, Susan has successfully led her Quality teams in supply chain management, production scale-up, tech transfer both inside and outside of the US, market launches, QMS integration and streamlining, and post-market activities.
Her former employers include several Class III and neuromodulation companies such as Thoratec Laboratory (now Abbott), Spinal Modulation (now Abbott), Oculeve (now Abbvie), and Presidio Medical.
Susan holds a BS in Chemical Engineering from the University of California, Berkeley.