Supplier Quality Engineer Consultant II
Until the year end
10 - 15 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 per21CFR820.80(b). Requires resiliency, and a demonstrated capability with 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 (subparts of PPAP, AS9102, EN9102) 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.
APN Software Services, Inc.
39899 Balentine Drive, Suite 385, Newark, CA 94560