Bonnie Qiu, MSc, LSSMBB, PRRC

Senior Director, Quality Assurance and Regulatory Affairs at Biomerica, Inc.
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Contact Information
us****@****om
(386) 825-5501
Location
Irvine, California, United States, US
Languages
  • English -
  • Chinese (Mandarin) Native or bilingual proficiency

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Eric Whitters PhD.

I had the pleasure to work with Bonnie for a number of years, interacting with her daily (and sometimes hourly) for a number of key projects at DPC. Although Bonnie was at first reserved in her role in the department, she evolved over the years and industrialized her work such that every detail & every project was accurately monitored for progress. She was the ultimate project manager since she could handle many, many projects at the same time - for example, her work in magnetic particles covered multiple product offerings/formats (>10) being converted from traditional bead-based immunoassays to the new solid phase. And, she did this with limited scientific and program management resources - miraculous! Bonnie was rightfully proud of her contribution to the larger organization. I believe her greatest contribution, however, was her intense work effort that exemplified her passion for doing a good job, getting it done on time and getting it done right the first time so she could move on to new challenges in the scientific world.

Esther Reichstein

I have worked with Bonnie Qiu at Diagnostics Product Corporation for over 5 years as part of the development team for a large immunoassay instrument, IMMULITE® 3500 PMLP-based immunoassay instrument. We met bi-weekly in conference calls between the Instrument Systems Division in New Jersey where I am located and the Assay Development group in Los Angeles where Bonnie was located. Bonnie was hardworking and her group was very productive. The project required good team work from the engineering and reagent teams since the technology was changed from 6 mm beads to magnetic microparticles and there was a new approach to the separation and wash of the microparticles. This required that Bonnie and her group work on microparticle coating protocols and developing assays mainly on breadboards and only later on prototype instruments. Bonnie was able to lead her team to work effectively with the uncertainty both in the hardware and the reagents and interacted both cross site and cross functionally with Systems Engineers. This experience will allow Bonnie to work both in chemical reagent and hardware projects.

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Credentials

  • Lean Six Sigma Master Black Belt
    SSD Global Solutions
    Aug, 2017
    - Nov, 2024
  • Lean Six Sigma Black Belt
    SSD Global Solutions
    Mar, 2011
    - Nov, 2024

Experience

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Senior Director, Quality Assurance and Regulatory Affairs
      • Mar 2021 - Present

    • Director, Quality Assurance and Regulatory Affairs
      • Mar 2019 - Mar 2021

    • Senior Director, Quality Assurance and Regulatory Affairs
      • Mar 2021 - Present

    • Director, Quality Assurance and Regulatory Affairs
      • Mar 2019 - Mar 2021

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • Staff Quality Assurance / Risk Management
      • Jan 2018 - Mar 2019

    • United States
    • Medical Equipment Manufacturing
    • 700 & Above Employee
    • Staff Quality Assurance / Risk Management
      • 2012 - 2017

    • United States
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • Assay Development Project Manager, Consultant
      • 2011 - 2011

    • Hospitals and Health Care
    • 700 & Above Employee
    • Assay Development Manager / Project Manager
      • 2006 - 2010

    • Assay Development Manager / Project Manager
      • 2006 - 2010

    • Medical Equipment Manufacturing
    • 100 - 200 Employee
    • Assay Development Senior Research Scientist / Project Manager
      • 1999 - 2006

    • Assay Development Research Scientist
      • 1996 - 1999

Education

  • Regulatory Affairs Professionals Society (RAPS)
    Regulatory Affairs Certification (RAC)
    2016 - 2019
  • SSD Global Solutions
    Lean Six Sigma Master Black Belt Certification
    2017 - 2017
  • Institute of Project Management
    Project Management Professional (PMP) Certification
    2010 - 2011
  • SSD Global Solutions
    Lean Six Sigma Black Belt Certification
    2010 - 2011
  • Anhui University
    Bachelor of Science (B.S.), Biochemistry and Microbiology
    -
  • California State University-Los Angeles
    Master of Science (M.S.), Biology (Molecular Biology)
    -

Community

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