Find an Expert
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…
Expert in Manufacturing and Quality of Casting Methods, Problem Solving
Expert is an accredited Industrial Engineer with more than 16 years in the field. In his former employment position, he has served for 11 years as Senior Commodity Manager of Cast Products, working on major automotive and aerospace engineering and…
Expert in Apparel Productivity, Ethical Compliance and Quality Management in Underdeveloped Countries
Expert has thirty years experience in quality management starting when this discipline was in its infancy in 1981. Wrote and instituted the original standards and procedures for Gap and managed their US and Caribbean suppliers. Subsequent to that he worked…
Expert in Beverage Packaging, Glass Bottles, R&D, Packaging Standards and Supplier Qualifications
Expert has applied his business and engineering training in the development of packaging systems (cans, bottles, and kegs) within the brewing industry. These designs have ranged from bottles or cans developed for specific brand related objectives, to the rationalization of…
Expert in Quality Control, Quality Assurance, ISO9000, Forensic Pathology, Products Liability
Expert has over 40 years of progressively increasing experience in business beginning as an electronics technician, production planner, quality control engineer, quality manager, manufacturing manager, director of training and finally as a consultant, senior consultant, expert witness and now a…
Expert in ERP and Software Package Contract negotiation for customers, SLA\’s and Quality Assurance
Expert helped implement ISI9001:2000 in many software organizations. He also teaches graduate students and conduct research in this field. He is a member of the ISO committee that updates the international standards (TC 156). His specialty is software so he…
Expert in Automotive Supplier Development Engineer
He has experience of Continuous improvement activities at automotive and general product supplier sites has achieved Problem resolution using global 8D to address both plant and customer satisfaction issues. He is experienced in Problem prevention by the implementation of APQP,…
Expert in Pharmaceutical Quality Assurance
He possess thorough knowledge of GMP / GLP regulations like US FDA, WHO GMP, ICH, MHRA, ANVISA, requirements of cGMP documents (SOP’s/ Change controls/ Deviations) as per various regulatory agencies. He had actively participated in various international regulatory inspections (USFDA…
Expert in Quality Assurance Engineering
Expert has over 15 years of experience with quality assurance. He provided Quality Assurance support to insure timely and cost effective: systemic, design, component and product compliance. His activities included supporting: New Product Development, Design Reviews, Verification and Validation, Material…
Expert in Quality Management
QUALITY MANAGEMENT; CONTINUOUS QUALITY IMPROVEMENT. Ms. Expert has extensive background and hands-on experience in the management and implementation of quality improvement, as well as TQM (total quality management) and continuous improvement. Her experience includes implementation, planning, analysis, training, and measurement…