Must possess two 2 years of experience with each of the followingbr br DMAIC, Root Cause Analysis, CAPA, PFMEA, and control and monitoring plans.br Analytical and system toolsbr IQOQPQ and process changesbr GDT, Gage RR, MSA, and statistical analysisbr FACTORYworks MES, Trackwise, and Agile QMSbr cGMPs, cGDPs, USP, and FDA QSRbr FDA 21 CFR Parts 210, 211, 820, Part 4 and Part 11, and ISO 14644, ISO 13485 and ISO 14971
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