Shaun Ooi

Shaun Ooi has a diverse work experience in quality engineering and regulatory affairs. Shaun is currently serving as the Director of Quality Engineering & Regulatory Affairs at XII Medical since January 2022. Before that, they worked at DawnLight as a Senior Manager in the same field from 2021 to 2021.

Prior to these roles, Shaun worked at Johnson & Johnson, starting as a Principal Quality Engineer in New Product Development from 2016 to 2019. Shaun then transitioned into the position of R&D Quality Engineering Manager, where they served from July 2019 to February 2021.

Shaun also has experience as the Co-Founder and CEO of Quality Devices LLC from December 2018 to January 2021. Furthermore, they worked at Abbott as a Senior Supplier Quality Engineer from June 2014 to July 2016.

Overall, Shaun Ooi has showcased their expertise and leadership skills throughout their various roles in quality engineering and regulatory affairs within different companies.

Shaun Ooi completed their Bachelor and Master of Science (BS/MS) degree in Chemistry and Biochemistry at UC San Diego from 2006 to 2012. Later, they pursued a Master of Business Administration (MBA) degree at the University of California, Berkeley, Haas School of Business from 2019 to 2022. In terms of certifications, Shaun obtained the Six Sigma Green Belt (CSSGB) certification from ASQ - World Headquarters in June 2016, the Certified Manager of Quality / Organizational Excellence (CMQ/OE) certification in November 2018, the Certified Medical Device Auditor (CMDA) certification in September 2020, and the Project Management Professional (PMP) certification from the Project Management Institute in July 2017.