Lei F.
Staff Quality Assurance Engineer @Life Technologies
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WORK HISTORY
Staff Quality Assurance Engineer @Life Technologies
San Diego, CA, US
Lead quality assurance guidance for projects including: cloud based DNA sequencing data analysis software/algorithm development, NGS/cancer detection/precision medicine discovery, flow cytometry chemical performance and chemistry flow improvement, and GeneMapper software platform update.• Lead quality assurance guidance for design planning, design input/output, design verification, design validation, test method validation, risk management process, FMEA, and design reviews.• Review design control plan/protocol/report, and draft quality and risk management plan/report.• Lead continuous improvement of the Quality Systems, including the design control, document generation, risk management process, and software life cycle management. • Support production for quality assurance, manage CAPA process and root cause analysis. • Provide guidance on test methods, equipment acquisition, sample plan definition, and validation development. • Provide guidance and decisions on product development activities to ensure continued compliance with internal procedures, and applicable regulatory and international standards, including ISO 9001, ISO 13485 and ISO 14971.
EDUCATION
Singapore MIT Alliance
Master's degree
Peking University
Bachelor of Science (B.Sc.)
Case Western Reserve University
Doctor of Philosophy (Ph.D.)
ABOUT LEI F.
Ph.D in Chemical Engineering with 10 years of combined quality assurance, design control, validation and new product development experience in ISO 13485 medical device industry. • Managed more than 20 NPI projects, including compliance, risk management process, product design validation, manufacturing and testing processes/equipment validation, IQ, OQ and PQ. • CQE, Certification of Quality Engineer from American Society of Quality. • Lean six sigma black belt. • Collaborated with cross-functional teams to transferred R&D processes to production, implemented FMEA, Design for Manufacturability and Design for Reliability. • Excellent communication skills and project management experience. Specialties: Electrochemical sensor, coagulation sensor, glucose sensor, lactate sensor, oxygen sensor, ISE sensor, biosensor, enzyme sensor, thin film, thick film printing, micro fabrication, nano material, medical device, blood gas sensor, device failure analysis, process optimization, KAIZEN. A3 management process, PSP (problem solving process), SEM, XRD, materials characterization. IQ, OQ and PQ.
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