Shaun Ooi

Director, Quality Engineering & Regulatory Affairs at XII Medical
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Contact Information
us****@****om
(386) 825-5501
Location
US

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Credentials

  • Six Sigma Green Belt (CSSGB)
    ASQ - World Headquarters
    Jun, 2016
    - Nov, 2024
  • Certified Manager of Quality / Organizational Excellence (CMQ/OE)
    ASQ - World Headquarters
    Nov, 2018
    - Nov, 2024
  • Certified Medical Device Auditor (CMDA)
    ASQ - World Headquarters
    Sep, 2020
    - Nov, 2024
  • Project Management Professional (PMP)
    Project Management Institute
    Jul, 2017
    - Nov, 2024

Experience

  • XII Medical
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Director, Quality Engineering & Regulatory Affairs
      • Jan 2022 - Present

  • DawnLight
    • United States
    • Software Development
    • 1 - 100 Employee
    • Senior Manager, Quality Engineering & Regulatory Affairs
      • Jan 2021 - Dec 2021

  • Johnson & Johnson
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • R&D Quality Engineering Manager
      • Jul 2019 - Feb 2021

    • Principal Quality Engineer, New Product Development
      • Jul 2016 - Jul 2019

  • Quality Devices LLC
    • United States
    • Medical Equipment Manufacturing
    • Co-Founder & CEO
      • Dec 2018 - Jan 2021

  • Abbott
    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Sr. Supplier Quality Engineer
      • Jun 2014 - Jul 2016

Education

  • University of California, Berkeley, Haas School of Business
    Master of Business Administration - MBA
    2019 - 2022
  • University of California San Diego
    Bachelor & Master of Science (BS/MS), Chemistry and Biochemistry
    2006 - 2012

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