Find an Expert
Medical Device & Pharmaceutical Quality Systems; Regulatory. Affairs; Quality Fitness Reviews
Advised and trained Operations and QA employees in a large pharmaceutical plant on effective practices to investigate and document deviation events on the manufacturing floor and quality control laboratory. The aim of such investigations was to determine a root cause…
Metallurgical and Materials Engineering, Problem Solving
While Expert is a degreed materials engineer and licensed metallurgical engineer, he approaches all assignments as problem-solving projects. Whether it be plaintiff-subrogation or defense litigation, manufacturing and quality optimization, accident investigation, or assistance with team accreditation, he applies his background…
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…
Systems Engineer & Mechanical Engineer
Expert is a proud Systems Engineer, Mechanical Engineer, and research associate with over 15 years of experience performing ground breaking research, analyzing business operations, and supporting business solutions. His aim is to utilize his research, engineering, project management, IT proficiency,…
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,…
Pet Food Manufacturing, Marketing, Quality Systems, Formulation, and Regulation
Over 30 years in the pet food industry with expertise in product development, nutrition, ingredients, manufacturing, packaging, regulatory (FDA/USDA/CFIA/organic), import/export, Quality Systems, and working with people.
Motor Vehicle Safety
Expert's product hazard consulting firm offers leading expertise in product injury issues. He has worked in injury control for 30+ years as an educator, researcher, author, expert witness, filmmaker, and historian. He was a principal architect within the Insurance Institute…
Process Development, Commercialization, Scale-Up; Separation and Purification – Filtration, Activated Carbon
During his career, Expert functioned as a senior-level executive (Senior VP positions) with over 40 years of experience in the Chemical Process and Materials industries. His track record is characterized by: merger and acquisition experience, development of new product lines…
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…
air and hydraulic brake systems and products. Mobile equipment hydraulic powered lift mechanisms
Global product related planning, development, application, support engineering; engineering and business unit management of mechanical, electromechanical, pneumatic and hydraulic products and systems in the mobile commercial vehicle industry. Cross functional experience beyond product engineering including project management, purchasing, supplier selection…