Lssmbb Bonnie Qiu Email & Phone Number
Senior Director, Quality Assurance and Regulatory Affairs @ Biomerica, Inc.
Location
Irvine, CA, US
Work
- Senior Director, Quality Assurance and Regulatory Affairs @ Biomerica, Inc.
- Director, Quality Assurance and Regulatory Affairs @ Biomerica, Inc.
- Senior Director, Quality Assurance and Regulatory Affairs @ BioEurope GmbH
- Director, Quality Assurance and Regulatory Affairs @ BioEurope GmbH
- Staff Quality Assurance and Risk Management @ Abbott
- Staff Quality Assurance and Risk Management @ Beckman Coulter
- Assay Development Project Manager, Consultant @ Hycor Biomedical
- Assay Development Manager and Project Manager @ Siemens Healthcare
- Assay Development Manager and Project Manager @ Siemens Healthcare Diagnostics
- Assay Development Senior Research Scientist and Project Manager @ DPC
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))
Skills
- Leadership
- Six Sigma
- Design Control
- Immunoassays
- Clinical Trials
- Verification and Validation V&V
- Root Cause Analysis
- GMP
- Hardware Diagnostics
- Infectious Diseases
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