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Supply Chains, Quality Assurance, Operations and Procurement Strategy
Project Management professional with wide range of project life-cycle experience that target quality improvement, financial health and operational efficiency in various industries. AREAS OF EXPERTISE Requirements gathering, Project Management Methods, Certified Project Manager, Process Optimization & Mapping, Risk Analysis, Use…
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…
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,…
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…
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…
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…
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…
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…
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,…
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…