Masters degree in Industrial Engineering, Manufacturing Engineering, Biotechnology, Biomedical Engineering, or related engineering field and five 5 years of experience as a quality applications specialist, quality engineer, or related occupation performing quality applications.br br Must possess a minimum of five 5 years of experience with each of the followingbr br Quality engineering support for development and VV activitiesbr GAMP5 and Risk based validation, compliance with FDA regulations 21 CFR Parts 11 and 820, ISO 13485, 14971 and GMPbr Computer System Validation, Report Validation, Spreadsheet Validation, Software Testing Release Equipment Validationbr QSR including CAPA and remediation efforts and tools to include Agile PLM, Trackwise, Smartsolve and Cornerstonebr Enterprise Applications to include SAP, JIRA and Agile PLMbr Electronic Laboratory Mgmt. systems to include Waters and ELogbooksbr br May work remotely within area of intended employment.

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