Requires a Bachelors degree or foreign degree equivalent in Engineering or related field and 5 years of experience in quality functions engineering or regulatory compliance role or related position. Must have 5 years of experience understanding and applying Quality System Regulations associated practices and standards ISO, 21CFR, etc. governing the design, manufacturing, distribution and surveillance of medical devices; must have 5 years of experience with knowledge of design for manufacturing and inspection, statistics, process control, and process capability with hands on quality system process experience; must have 4 years of experience with navigating the product development lifecycle, including NPI design control, supplier and manufacturing transfer, and PostMarket processes; must have 2 years of experience supporting internal and external compliance functions, such as audits, QSRISO training, trend analysis, etc.; and must have 2 years of experience with demonstrated independent decisionmaking and peoplemanagement abilities including effective employee selection, development, motivation, and performance improvement.br br Telecommuting work arrangement permitted position may work in various unanticipated locations throughout the U.S.

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