Senior Quality Engineer - Med Device & Data Analytics

Regulatory Jobs; Roseville (CA); On-site; USD 135,000 - 175,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with employer match

Paid parental leave

Holiday and vacation accruals

Job summary

Penumbra, Inc. in Roseville, CA seeks a Principal Quality Engineer to drive quality improvement across Operations and champion systematic problem solving. You will lead NCRs/CAPAs, develop CTQ flowdowns, and architect scalable quality systems leveraging SPC, analytics, and automation.

The role requires 7+ years in medical device quality engineering and a strong foundation in LeanSixSigma, FDA QSR, and ISO 13485. Travel and lab work may be required.

Qualifications

• Bachelor’s degree in Engineering (Biomedical, Mechanical, Materials, Chemical, or related discipline preferred); advanced degrees strongly preferred.
• 7+ years of experience in Quality Engineering, Continuous Improvement, or Manufacturing Engineering within the medical device industry.
• Experience in Lean and Six Sigma methodologies, leading large-scale continuous improvement, Cost of Quality reduction, or CTQ deployment programs.
• 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.
• Deep expertise in inspection technologies, destructive testing, sampling theory, and measurement system analysis.
• Experience implementing automation, digital quality systems, or advanced analytics platforms.
• Strong collaboration with Manufacturing Engineering, Industrial Engineering, Equipment Engineering, and R&D.
• Ability to thrive in a dynamic, fast-paced environment while influencing long-term quality strategy.

Responsibilities

• Lead cross‑functional continuous improvement initiatives focused on reducing Cost of Poor Quality, improving process capability, and strengthening CTQ/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, SPC, 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.
• Influence long‑term quality strategy, including technology adoption, digital quality transformation, and advanced analytics integration.
• Train and mentor Quality Engineers, elevating technical capability and fostering a culture of scientific thinking and continuous improvement.

Skills

Quality Engineering

Continuous Improvement

Lean Six Sigma

Statistical Analysis

DOE / Experimental Design

Education

Bachelor's degree in Engineering

Advanced degree preferred

Tools

Statistical Process Control

Automation systems

Quality systems software

Job description

Penumbra, Inc. in Roseville, CA seeks a Principal Quality Engineer to drive quality improvement across Operations and champion systematic problem solving. You will lead NCRs/CAPAs, develop CTQ flowdowns, and architect scalable quality systems leveraging SPC, analytics, and automation.

The role requires 7+ years in medical device quality engineering and a strong foundation in LeanSixSigma, FDA QSR, and ISO 13485. Travel and lab work may be required.