Quality Assurance Specialist

Quality Assurance Specialist8-month contractOnsite in Portland, MEKey responsibilities:Lead incoming, in‑process, and final inspectionsManage sterilization validations and sterile loadsOversee NCs, MRB, complaint investigations and failure analysisCoordinate CAPA lifecycle, root‑cause analysis and closureInterface with suppliers, contract manufacturers and consultantsSupport internal audits, calibration, receiving inspection and quality metricsQualifications:2+years in medical device, pharma or biotech (device preferred)Strong experience with NCs, CAPA and RCAFamiliar with FDA QSR (21 CFR 820), ISO 13485Experience with electronic QMS and sterilization preferredBachelor’s degree preferred