Hiring: Principal Quality Engineer Company: Penumbra, Inc. Location: Roseville, CA Job Posted Time: 2026-09-16 16:18:07 Target Skills & Keywords : R, Six Sigma About the job Experience: •Deep expertise in inspection technologies, destructive testing, sampling theory, and measurement system analysis. •Strong collaboration with Manufacturing Engineering, Industrial Engineering, Equipment Engineering, and R&D. •Demonstrated capacity to thrive in a dynamic, fast‑paced environment while influencing long‑term quality strategy. Required Skills: •Lead cross-functional continuous improvement initiatives focused on reducing Cost of Poor Quality, improving process capability, and strengthening Critical to Quality performance across manufacturing operations. •Identify, quantify, and prioritize systemic quality improvement opportunities using data‑driven methods, advanced analytics, and structured problem‑solving frameworks. •Own complex NCRs and CAPAs, and participate in NCR boards •Develop and deploy CTQ flowdowns, ensuring alignment between product requirements, process controls, and inspection strategies. •Architect and optimize quality monitoring systems, including predictive analytics, statistical process control, and automated data visualization tools. •Lead high‑complexity problem-solving efforts using advanced statistical and scientific methods (DOE, regression modeling, multivariate analysis, reliability modeling). •Drive continuous improvement of inspection systems, test methods, and measurement capability, including automation, sampling optimization, and risk‑based acceptance strategies. •Champion Lean, Six Sigma, and operational excellence methodologies, setting direction for waste reduction, variation control, and process robustness. Qualifications: •Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related discipline preferred); advanced degree strongly preferred. •7+ years of experience in Quality Engineering, Continuous Improvement, or Manufacturing Engineering within the medical device industry. •Expert‑level 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. •ASQ CQE, CSSBB, or equivalent advanced quality certification. Compensation: •$135,000 - $175,000 / year •We offer a competitive compensation package plus a benefits and equity program, when applicable Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!