Lead Quality Architect, Medical Devices

Penumbra, Inc.; Roseville (CA); On-site; USD 135,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) with employer match

Paid parental leave

Vacation and holidays

Job summary

Penumbra, Inc. in California seeks a Principal Quality Engineer to lead quality improvement across Operations, driving capability, inspection optimization, and robust manufacturing processes.

You will apply advanced analytics and structured problem solving to strengthen CTQ performance while guiding a culture of operational excellence. You will influence quality strategy, mentor engineers, and champion digital quality transformation across the organization, with strong cross-functional

Qualifications

• Bachelor’s degree in Engineering; advanced degree strongly preferred.
• 7+ years in Quality Engineering, Continuous Improvement, or Manufacturing Engineering in the medical device industry.
• Expert understanding of FDA QSR and ISO 13485 in a manufacturing context.
• Proven ability to lead cross-functional teams through complex technical challenges and strategic quality initiatives.
• Advanced data analysis, statistical modeling, and decision-making skills.

Responsibilities

• Lead cross-functional continuous improvement initiatives focused on reducing cost of poor quality and strengthening critical-to-quality performance.
• Identify, quantify, and prioritize systemic quality improvement opportunities using data-driven methods and structured problem-solving.
• Own complex NCRs and CAPAs and participate in NCR boards.
• Develop CTQ flowdowns aligning product requirements, process controls, and inspection strategies.
• Architect and optimize quality monitoring systems, including predictive analytics and SPC.
• Lead high-complexity problem-solving with DOE, regression modeling, multivariate analysis, and reliability modeling.
• Drive continuous improvement of inspection systems, testing, and measurement capability.
• Champion Lean, Six Sigma, and operational excellence methodologies.
• Influence long-term quality strategy including digital quality transformation and analytics integration.
• Train and mentor Quality Engineers to foster scientific thinking and continuous improvement.

Job description

Penumbra, Inc. in California seeks a Principal Quality Engineer to lead quality improvement across Operations, driving capability, inspection optimization, and robust manufacturing processes.

You will apply advanced analytics and structured problem solving to strengthen CTQ performance while guiding a culture of operational excellence. You will influence quality strategy, mentor engineers, and champion digital quality transformation across the organization, with strong cross-functional