Supplier Quality Engineer II (Onsite – 80%+) in Irvine, CA Travel: Up to 25% (domestic & international)Position OverviewThe Supplier Quality Engineer II will support design and development teams in qualifying critical materials and suppliers for innovative, life-saving medical devices. This role ensures supplier compliance with internal and regulatory requirements while collaborating cross-functionally with R&D, Operations, Quality, Sourcing, and Regulatory Affairs.Key ResponsibilitiesQualify and manage suppliers for OEM/custom materials and componentsEnsure compliance with FDA and global regulatory standardsSupport supplier audits, validation, and risk management activitiesDevelop and validate inspection/test methods for incoming qualityDrive root cause investigations (NCR, CAPA, SCAR) and corrective actionsSupport Design Development File and design control requirementsApply statistical and quality engineering tools (dFMEA, Gage R&R, RCA)Required QualificationsBachelor’s degree in Engineering or related Scientific field2+ years of experience in Supplier Quality, Manufacturing, or Quality EngineeringExperience in a highly regulated industry (Medical Device preferred)Preferred QualificationsExperience with Class II or Class III medical devicesKnowledge of FDA & international medical device regulationsExperience conducting supplier/vendor auditsStrong problem-solving and statistical analysis skillsSix Sigma/Lean or ASQ certification (CQE/CQA) preferred