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Quality Engineering Manager

Quality Engineering Manager (Medical Device)Location: Alameda, CA (Onsite)Comp: $179 - $190K base with equity packageOverviewWe're partnering with a high-growth medical device company seeking a Quality Engineering Manager to lead a team supporting manufacturing operations and production lines. This role sits within Technical Operations and plays a key part in driving yield, process control, and overall manufacturing quality performance.Key ResponsibilitiesLead and develop a team of Quality Engineers supporting productionOwn manufacturing quality metrics (yield, scrap, productivity, throughput)Partner cross-functionally with Manufacturing, Production, and Industrial EngineeringDefine and improve inspection strategies (in-process, final, sampling, testing)Drive continuous improvement using Lean/Six Sigma methodologiesOversee NCRs, CAPAs, MRB, and process investigationsSupport risk management (pFMEA, CTQs) and equipment validation activitiesEnsure processes are capable, controlled, and compliantQualificationsBS in Engineering (Mechanical, Biomedical, Materials, etc.)5+ years in Quality or Manufacturing Engineering (medical devices required)1+ years of leadership or strong readiness to leadExperience with FDA QSR / ISO 13485Strong problem-solving and data-driven mindsetNice to HaveCatheter-based or nitinol device experienceHigh-volume manufacturing or commercialization ramp exposureInspection systems, DOE, statistical analysisLean/Six Sigma or CQE

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