The Quality Engineer facilitates the daily activities related to the inspection functions and provides leadership and motivation to achieve the desired level of quality and delivery to internal and external customers. They will apply the understanding, use, and application of standards and specifications including ISO 9001, AS9100, Nadcap, ITAR, ISO 13485, ISO 14971, and FDA 21CFR Part 820.
REQUIRED EXPERIENCE AND SKILLS:
5+ years of experience as a Quality Engineer in an aerospace or medical device manufacturing environment
5+ years of experience with AS9100 or ISO 13485 quality standards (both are preferred)
Experience with leading quality investigations and CAPA
Experience with creating and executing validation protocols (IQ, OQ, PQ)
Experience with NADCAP or FDA 21CFR Part 820 (both are preferred)
BS in Engineering
DESIRED EXPERIENCE AND SKILLS:
ASQ Certification
Experience with ISO 14971 risk management standards