Supplier Quality Engineer
Location: Andover, MA
Duration: Until the year end
Description:
Experience: 4 - 8 years professional experience in the role described below. Education: Bachelor's degree in Engineering. Individual contributor role responsible for steering a cross functional team to determine new standards for product inspection and acceptance per 21CFR820.80(b). Requires demonstrated capability and strong technical aptitude in multiple medical device commodities. Role will require discipline to follow a prescribed execution plan, and an aptitude to navigate broad technical requirements while driving completion of tasks to predictable deadlines. Experience with FDA QSR supplier controls mandatory, experience with QSR design controls desirable. Experience with FAIR requirements according to typical industrial standards desirable. Also desirable to possess knowledge or experience with CPK, APQP, Process Capability Statistics in relation to Six Sigma, and functional understanding of QSIT, and remediation activities relative to QSR.