Sr. Supplier Quality Engineer II

Role: Supplier Quality Engineer II supporting supplier quality for medical devices and pharmaceuticals at Glaukos. Responsibilities: manage supplier qualification, onboarding, risk assessments, and record-keeping; monitor supplier performance, initiate and track SCARs, investigations, root cause analysis, and corrective actions; support supplier audits and assessments, document findings, and coordinate follow-up; collaborate internally and externally to resolve quality issues and implement compliant supplier changes; travel periodically for audits and reviews. Requirements: Bachelor's in Engineering, Science, Quality, or related; 2+ years in Supplier Quality, Quality Engineering, or manufacturing quality in a regulated environment; experience with supplier qualification, audits, and CAPA; knowledge of FDA QSR, GMP, ISO 13485, and root cause analysis; strong communication, organizational, and multitasking skills. HighValue: medical device/pharma manufacturing, supplier qualification & audits, GMP, ISO 13485, CAPA, regulated environment. WorkSetup: on-site Aliso Viejo, CA; periodic travel.