Main job focus in Medical Device manufacturing, with the current supportive role as Operations Coordinator and former Quality Assurance experience in quality systems auditing, batch release, healthcare labeling, deviations, customer complaints and CAPA. Knowledge of 21 CFR Parts 820, 210 and 211. Understanding of ISO 9001:2000 requirements. Some experience in re-validation of equipment systems and re-qualification of facilities.
DOS and Windows XP
Document Management: Web Based Documentum, Zyqad, SAP
Science Earned approximately 120 credit hours
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