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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…
Steel Tube Technology Management, QMS, EMS, OHSAS, TQM, Stretch Target Process/ Product Development
General: Proficiency in the primary areas A post graduate in Metallurgy ( univ gold Medalist) and an MBA with 37 years of primary expertise in the following major areas: 1. Quality Management, Quality Assurance 2. Product and process development 3.…
Chemical Engineering, Trouble Shooting of Chemical Plants, Fats & Oils, Biodiesel, Biofuels
Expert is a chemical engineer with master’s degree in Business Management. Expert has over 22 years of experience in large Oleo chemical oil refineries, petrochemicals and fertilizer industries in Asian countries. He has been involved in successful troubleshooting of various…
ISO 9001-2000/TS 16949 audits, documentation, training, assistance for certification, APQP, SPC
Expert is an ISO 9000 Lead auditor. He has been implementing developed by ISO like ISO 9000, ISO 13485, and ISO 17025 for many years. He has assisted several companies from various industries to become certified from scratch. He has…
Quality Management Systems and Engineering Ceramics
Expert W. Expert has extensive experience with implementing and managing the ISO 9000 series of quality standards. He became an ISO Lead Auditor at Corning, Inc. He used his knowledge to implement and pass the ISO 9000 quality systems at…
Software Quality & Life Cycle, ISO 9000 Standards, Software Regulatory Issues, etc.
Ms. D. Expert has extensive expertise with the maintenance, re-engineering, and reuse of computer software. She has maintained large telecommunications systems and established processes that resulted in effective provision of service to company engineers. She was the Chair of a…
Quality Assurance Systems and Training
Ms. Expert has worked with numerous large and small organizations to establish and implement TQM processes. This process starts with an internal evaluation, then continues with policy and mission statements and the establishment of a steering committee to draw up…