Quality Engineering Manager

Benefits

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Schedule

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Application

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About this role

Quality Engineering Manager Alameda, CA General Summary In this role, you will lead a team of Quality Engineers supporting manufacturing operations and production lines for a portfolio of medical devices. You will be accountable for manufacturing quality performance, inspection strategy, yield improvement, and sustaining process control, from early commercial ramp through product maturity and site transfer. Embedded within Technical Operations, this role partners closely with Manufacturing Engineering, Production, and Industrial Engineering to build quality into manufacturing processes from the start. From a quality-first perspective, you will ensure processes are capable, controlled, and appropriately de-risked through robust process controls, inspection strategies, and data-driven monitoring. Your work will directly influence product yield, productivity, and operational stability by preventing defects, detecting issues early, and ensuring consistent, compliant manufacturing performance. Specific Duties and Responsibilities •Lead Quality Engineering support for assigned product portfolios and production lines •Serve as the primary quality partner to Production, Manufacturing Engineering, and Industrial Engineering •Own manufacturing quality performance, including yield, scrap, productivity, and throughput-related quality losses •Own and advance inspection strategies, including in-process and final inspection, destructive testing, sampling plans, and acceptance/reject criteria •Drive continuous improvement of inspection systems, test methods, process monitoring, and digital quality tools •Apply Lean and Six Sigma methodologies to improve yield, reduce waste, and enhance process capability •Own execution of quality system activities within Operations, including NCRs, MRB, CAPAs, control chart investigations, and effectiveness verification •Champion process-based risk management, including pFMEAs and defining CTQs •Review and approve equipment-related quality activities, including equipment qualifications (IQ/OQ), equipment-related

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