About the job
Overview
Join our dynamic team at Penumbra, Inc. as a Manager of Quality Engineering, where you will spearhead a talented group of Quality Engineers dedicated to enhancing the manufacturing operations and production lines for our innovative range of medical devices. Your leadership will be pivotal in ensuring the highest standards of manufacturing quality performance, developing effective inspection strategies, optimizing yield, and maintaining robust process controls throughout the product lifecycle, from initial commercial ramp-up to product maturity and site transfer.
As a key member of our Technical Operations team, you will collaborate closely with Manufacturing Engineering, Production, and Industrial Engineering to embed quality into the manufacturing processes from the outset. With a commitment to quality excellence, you will implement effective process controls, inspection strategies, and data-driven monitoring to mitigate risks. Your efforts will directly contribute to improved product yield, enhanced productivity, and operational stability by preventing defects, identifying issues at their inception, and ensuring a consistent, compliant manufacturing performance.
Key Responsibilities
• Provide leadership for Quality Engineering across assigned product portfolios and production lines.
• Act as the primary quality liaison for Production, Manufacturing Engineering, and Industrial Engineering.
• Oversee manufacturing quality performance metrics, including yield, scrap, productivity, and throughput-related quality losses.
• Develop and refine comprehensive inspection strategies, including in-process checks, final inspections, destructive testing, sampling plans, and acceptance/rejection criteria.
• Initiate and lead continuous improvements in inspection systems, testing methodologies, process monitoring, and digital quality tools.
• Employ Lean and Six Sigma principles to enhance yield, minimize waste, and improve process capability.
• Manage quality system activities within Operations, including Non-Conformance Reports (NCRs), Material Review Board (MRB) activities, Corrective and Preventive Actions (CAPAs), control chart investigations, and effectiveness verification.
• Advocate for process-based risk management, including performing process Failure Mode and Effects Analyses (pFMEAs) and defining Critical to Quality (CTQ) metrics.
• Review and endorse equipment-related quality tasks, such as equipment qualifications (IQ/OQ), equipment change orders (ECOs), non-standard maintenance activities, and equipment software validation, in collaboration with Manufacturing Engineering.
• Recruit, develop, and manage a team of Quality Engineers, overseeing workload and FTE planning to align with production priorities.
*Essential functions of the role.
• Act as the primary quality liaison for Production, Manufacturing Engineering, and Industrial Engineering.
• Oversee manufacturing quality performance metrics, including yield, scrap, productivity, and throughput-related quality losses.
• Develop and refine comprehensive inspection strategies, including in-process checks, final inspections, destructive testing, sampling plans, and acceptance/rejection criteria.
• Initiate and lead continuous improvements in inspection systems, testing methodologies, process monitoring, and digital quality tools.
• Employ Lean and Six Sigma principles to enhance yield, minimize waste, and improve process capability.
• Manage quality system activities within Operations, including Non-Conformance Reports (NCRs), Material Review Board (MRB) activities, Corrective and Preventive Actions (CAPAs), control chart investigations, and effectiveness verification.
• Advocate for process-based risk management, including performing process Failure Mode and Effects Analyses (pFMEAs) and defining Critical to Quality (CTQ) metrics.
• Review and endorse equipment-related quality tasks, such as equipment qualifications (IQ/OQ), equipment change orders (ECOs), non-standard maintenance activities, and equipment software validation, in collaboration with Manufacturing Engineering.
• Recruit, develop, and manage a team of Quality Engineers, overseeing workload and FTE planning to align with production priorities.
*Essential functions of the role.
