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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…
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…
ISO 9001:2008 for plastic industry, Plastic Molding Processes, Metal Injection Molding process; Elec
He is RAB certified Lead Auditor for ISO-9001:2000:2008 since 1994, with second and third party auditing experience; He trained clients for ISO 9001:2008 QMS certifications and taught CMQOE (Certified Quality Manager’s) course through ASQ and Internal Auditor courses, and ISO…
OSHA; Construction Safety; Fall Protection; Working in Hot Environments
Expert has extensive experience as a safety professional in construction safety and insurance consultation. Areas of expertise include: Construction Safety, Safety Program Administration, OSHA Compliance Training Classes, Claims Management, Loss Trend Statistical Analysis (actual and potential), Accident investigation and inspection,…
Intellectual Property, Patents, Validity Invalidity, Infringement Noninfringement, Product Liabilty
Expert has extensive experience in product liability which include: Direct participation in more than 300 litigation cases with in-depth evaluations of multiple high-dollar claims and lawsuits. Forensic Analyses. Expert witness reports, inspections, accident reconstruction, photographs, occupant kinematics & injury causation,…
Telecommunications Infrastructure/ Plant Design (both inside and outside)
Extensive experience in designing telecommunication infrastructure systems including copper and fiber systems for inside (ISP) and outside (OSP) plant . Expert is a BICSI Master Instructor teaching design and installation to thousands of students worldwide. He has also created quality…
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,…
Medical Device Sterilization, Medical Device QA, GMP Audit, Supplier Audit, SOP\’s
Expert, Consulting Principal, is highly regarded in the medical device and sterilization industries. Areas of expertise include: medical device sterilization (Radiation and EO), quality systems development and assessment, sterilization management, medical device regulations, supplier auditing, internal auditing, nonconformity investigation and…
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…
Construction Safety
Expert has over 40 years' experience in worldwide professional safety. His work experience includes tenure as Corporate Safety and Security Director for four Engineering, Design and Construction Management Firms. This work has involved over 600 worldwide construction projects. Additionally, as…