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Expert ID: 736123 Indiana, USA

Expert in Medical Device Quality Assurance and Regulatory Compliance

Expert is a 34-year food, cosmetic, drug, biologic, clinical, medical device, and combination product non-technical quality assurance and regulatory compliance veteran with over 21 years of FDA/ governmental experience as an analyst and level II certified international medical device investigator…

Expert ID: 735921 Georgia, USA

Expert in Medical Device Quality Assurance and Compliance , FDA Medical Device Regulations, Quality Management Systems, Lean Six Sigma, Certified Six Sigma Master Black Belt

Expert is an extensively knowledgeable, self-motivated, and result-oriented Biomedical Engineer with an extensive background in quality and reliability engineering. Interested in verifying and validating solution designs, including detailed quality metrics in maintaining quality management systems that support and improve processes,…

Expert ID: 735946 Arkansas, USA

Expert in Consumer Product Safety, Regulatory and Retail Compliance, Quality Assurance

Expert is a consumer product (non-food) safety, regulatory and retail compliance, quality assurance and control, 3rd party lab testing / inspection / auditing, CPSC (Consumer Product Safety Commission), CPSIA (Consumer Product Safety Improvement Act), Federal / State / Local compliance…

Expert ID: 733959 California, USA

Expert in Metallurgy, Welding Engineering, and Quality Assurance in the Pressure Vessel and Piping Industry

Expert has worked in the pressure vessel and piping industry, since 1975. He has worked as a metallurgist, welding engineer, QA manager, and consultant, Expert's experience includes the design, fabrication, and operation of various power and refinery plant components, including…

Expert ID: 733849 Michigan, USA

Expert in Software Testing and Software Quality Assurance

Expert has over 20 years of experience testing a wide range of systems and applications software from internal applications to publicly-used applications and systems. His clients have ranged from start-ups to Fortune 500 companies, government, non-profits and multi-national corporations. He…

Expert ID: 731924 Illinois, USA

Expert in Quality Assurance, Regulatory Affairs, and New Product Development Consultant

BS Engineering, 30+ years in senior technical/management positions in Quality Assurance, Regulatory Affairs, and New Product Development space. Expert in medical device, in-vitro diagnostic, and pharmaceutical products and processes. Core competencies in Design Control, Risk Management, Validation and Verification, and…

Expert ID: 731839 California, USA

Expert in Quality Assurance, Fabrication, Work Process Control, Configuration Management

38 years of nuclear and other industry experience that has included work for nuclear power plants, fabricators, and spent fuel dry storage system installation providers. Expertise is primarily QA/QC including QA program development, training, implementation and management. Specific areas with…

Expert ID: 730680 Illinois, USA

Expert in Program Management, Quality Systems, Strategic Improvement Initiatives, Quality Assurance

During the 20 years professional life, Expert held a variety of global positions of increasing responsibility in all aspects of program and quality management including Portfolio management, New Product Introduction program management, Strategic Planning, Development on new product introduction methodology,…

Expert ID: 730387 United Kingdom

Expert in Software – Quality Assurance, Regulatory Affairs and Licensing

Expert has over 25 years experience of delivering software solutions/applications to healthcare industries, including R&D, Manufacture and point-of-care delivery (e.g. hospitals). This includes negotiating the difficult areas of licensing in Europe, the USA and beyond, accreditation and certification to ISO…

Expert ID: 730258 California, USA

Expert in Medical Device Regulatory Affairs, Quality Assurance, FDA 820 EU ISO 13485 510(k) & Medical Software

Lead and developed regulatory plan and strategy for Molecular Diagnostic System. Blood Analyzer, Gene Profiling Reagents, Blood Analyzer etc. Assembled with team regulatory submission and obtained 510(k) clearance, EU CE Mark, Health Canada, China SFDA, Mexico, Australia, South Korea, and…

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