Brian W. Renoe, PhD

Sr. Quality Scientist/Project Leader

In addition to successful Quality Systems experience in medical devices, clinical diagnostics and biological products/pharmaceutical industries,Brian has a diverse professional, business-experience base, plus, a strong scientific background with academic exposure. With more than 30 years professional history, Brian has demonstrated profitable business development, strategic planning, and product development competency. He has implemented new strategies and new testing in the highly regulated environment of clinical laboratory testing. Brian readily recognizes scientific concepts and ideas as business opportunities, and effectively transforms them into profitable businesses which span domestic and international markets. Brian has utilized his project management abilities to establish and execute strategic plans by effectively mobilizing material and human resources to reach business goals.

Brian has held positions such as Director of Bayer Biological Products Division (plasma donations testing), Vice President of Technology at CEM Corporation, Director of Instrument Products at Hamilton Company (directed and contributed to the development of multiple new instrument products and over 200 accessory products for worldwide markets), Program Director at BIOTRACK Inc. (pre-donation screening system), and Manager of Systems, R&D, Projects, and Strategic Planning at Abbott Laboratories. Brian has also served as a consultant for device design and product development and validation for numerous other companies. He has significant expertise in plasma collections testing and clinical laboratory management settings.


  • Quality Systems, Processes and Procedures (Assessments, Revisions, Training)
  • Corrective and Preventive Actions management and execution
  • Validation of Test Methods, Processes and Equipment
  • Design Control and Product Development
  • Quality assessments and re-engineering
  • FDA Inspection Preparations and Management
  • FDA Compliance for Device Design
  • FDA Compliance for Laboratory Operations
  • Creation and management of Quality Improvement Plans
  • FDA 483 Responses and Corrective Actions
  • Laboratory Operations, Validations, Qualifications & Management
  • Quality Control & Analytical Test Method Validations
  • Clinical Evaluations (IND, PMA, 510k)
  • EU Technical Files creation and management
  • Reagents and Assays Development
  • Technology assessment, evaluation and market fit
  • Instruments and Systems Development
  • Design Reviews and Evaluations
  • Project Management for Medical Device Development


Consultant, Owner, QUALITY STRATEGIC RESPONSE, Charlotte, NC

Director, (CLIA Qualified Laboratory Director), Bayer Corporation, Raleigh, NC

Vice President, Technology, CEM CORPORATION, Matthews, NC

Director of Instrument Products, HAMILTON COMPANY, Reno, NV

Program Director, Pre-donation Screening System, BIOTRACK INC., Mountain View, CA

Abbott Laboratories, Abbott Diagnostics Division, Abbott Park, IL

Strategic Planning (ADD)

Systems Manager (ADD)

R & D Manager (TDx Business Unit)

R & D Departments Manager (ADD)

Project Manager (ADD)

University of Virginia & Medical Center, Charlottesville, VA

Assistant Professor of Pathology and of Chemistry

Associate Director of Clinical Chemistry and Toxicology Laboratories


Postdoctoral Training in Clinical Chemistry; Washington University School of Medicine

Doctor of Philosophy, Analytical Chemistry and Master of Science, Chemistry; University of Illinois

Bachelor of Science in Chemistry with Distinction; Washington State University


Content Protected Using Blog Protector By: PcDrome.