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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 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 in Sterility Assurance Expert in terminal sterilization (Ethylene Oxide, Moist Heat, Radiation, Dry Heat) and Aseptic Processing to Medical Device and Pharmaceutical companies.
. Expert is President and Principal Consultant for his consulting company - a consulting LLC. Prior to going into consulting, he was Director of Corporate Quality Technology/ Sterilization Science, for Alcon a Novartis company where he was responsible for sterilization…
Expert in Food Safety and Quality
Expert is a professional food safety consultant and auditor who has been registered with SQF (the Safe Quality Food Institute) as such. He has accrued vast experience implementing food safety and quality assurance compliance systems for top-tier food manufacturing firms.…
Expert in Transformer Design and Manufacturing
Technical Specifications of Transformers: Expert has developed manufacturing experience of Power Transformers for PGNE, SCE, NYPA, LADWP, First Energy, Puget Sound Energy, City of Tacoma, LCRA, National Grid, EDF in the U.S. and BC: Hydro, Hydro One, Manitoba Hydro, Transalta,…
Expert in Textile & Apparel Manufacturing
Expert’s practical skills and application include the majority of manufacturing processes, including corporate finance, project costing, logistics and planning, cutting, sewing, finishing, quality, and distribution. He is qualified as a Qualified Instructor/Practitioner in GSD (General Sewing Data) and MTM (methods-time…
Expert in Flavors and Fragrances Manufacturing, Compounding and Sample Services
Expert has improved flavors manufacturing, flavors compounding and sample lab best practices across multiple international sites for a top multinational Fragrance and Flavors company. Expert applies this experience to evaluate facilities, develop and justify proposals to optimize and deploy practical…
Expert in Low Temperature Cofired Ceramic, Microsystems manufacturing, Six Sigma, Lean & Process Engineering
An accomplished professional that has increased yields to well over 90% and reduced flow times by over 75%. Developed new processes and products that have generated new customers and millions in sales. These new processes and products have generated 3…
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 in Foods, Home & Personal Care Product / Process Development, Supply Chain Operations, Quality & Safety Systems
Expert is an accomplished professional with extensive leadership experience with Unilever plc and as a management consultant with Compass Consulting. He has over 25-years’ track record of driving business growth by successful execution of value improvement programs across supply chain…