Bonnie Qiu

WORK HISTORY

EDUCATION

SKILLS

ABOUT BONNIE QIU

Dedicated and successful Quality & Regulatory professional with 25 years of experience in Quality Assurance, Regulatory Affairs, Regulatory Compliance, Immunoassay Product Development, and Technical Operations in the competitive IVD Medical Device industry. Ensure Immunoassay & Clinical Chemistry Reagent Kits and Instrumentation diagnostics devices are in compliance with applicable internal, domestic and international quality and regulatory requirements, FDA QSR, ISO, IVDD/IVDR, MDD/MDR, CMDCAS, and JPAL. Serve as Person Responsible for Regulatory Compliance (PRRC) and Management Representative. Host and manage internal audits, external audits by the FDA, EU Notified Bodies, other regulatory bodies, and customers. Develop and implement audit observation response strategies and action plans. Develop and implement Quality Management Systems: Design Controls/Risk Management, Change Controls, Document Controls, Deviation Controls, CAPAs, Non-Conformance Materials Control, Internal Audits, Management Reviews, Critical Supplier Quality Management, MDR Reporting, Product Recall, Product Labeling Control, Calibration and PM Programs, etc. per the FDA QSR, cGMP requirements, ISO 13485, EU MDR 2017/745, and EU IVDD 98/79/EC & IVDR 2017/746.In-depth knowledge of the FDA regulations and guidance (21CFR Part 820, Part 210, Part 211, Part 11, etc.), ISO standards (ISO 13485:2016, ISO 14971:2019), EU MDR 2017/745, EU IVDD 98/79/EC & IVDR 2017/746, Medical Device Single Audit Program (MDSAP), and other regulations/standards.Full understanding of risk management systems with practical experience in initiation of risk management programs, risk assessment methodologies, and clinical risk and benefit analysis. Expertise in area of Human Factor / Usability Engineering for incorporating design features to enhance/mitigate product use/misuse. Drive reliability objectives, customer use conditions, and design input criteria early in the development process to support Design for Reliability & Manufacturing (DRM) and Product Lifecycle Management (PLM).Strong management and leadership skills for building capable organizations through developing dynamic teams and creating objective-driven/results-oriented environments. Extensive experience in leading global multi-site, cross-functional teams toward achieving objectives by setting and executing strategies to improve Product Design & Development, Quality, and Manufacturing processes. M.S. in Biology, B.S. in Biochemistry and Microbiology, Lean Six Sigma Master Black Belt certified.