Principal Quality Engineer

As a Principal Quality Engineer, you will serve as a technical leader driving quality improvement across Operations. You will apply deep analyticalexpertiseto strengthen process capability,optimize inspection and monitoring systems, and elevate quality performance through structured continuous improvement methodologies.

This role requires structured Quality Engineering approaches,strongengineeringanalysis and methodologies, statistical experience, and the ability to architect scalable

Quality

Engineering systems that prevent defects, reduce variation, and enhance long‑term manufacturing robustness. You will influence quality strategy, develop new approaches to systemic quality challenges, and champion a culture of operational excellence across the organization.

Working cross‑functionally with Manufacturing Engineering, Industrial Engineering, Operations Leadership, and R&D, you will ensure that quality is proactively designed into processes, risks are systematically mitigated, and improvement opportunities areidentifiedand executed with rigor.

• Leadcross-functional continuous improvement initiatives focused on reducing Cost of Poor Quality, improving process capability, and strengthening Critic alto Quality performance across manufacturing operations.

• Identify, quantify, and prioritize systemic quality improvement opportunities usingdata‑driven methods, advanced analytics, and structured problem‑solving frameworks.

• Developanddeploy CTQflowdowns, ensuring alignment between product requirements, process controls, and inspection strategies.

• Architect andoptimizequality monitoring systems, including predictive analytics, statistical process control, and automated data visualization tools.

• Leadhigh‑complexity problem‑solvingeffortsusing 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, andrisk‑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.

• Trainandmentor Quality Engineers, elevating technical capability and fostering a culture of scientific thinking and continuous improvement.

• Bachelor’s degree in Engineering(Biomedical, Mechanical, Materials, Chemical, or related discipline preferred); advanceddegreestrongly 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,Costof Quality reduction, or CTQ deployment programs.

• Expert‑level understanding of FDA QSR and ISO 13485 in a manufacturing context.

• Proven ability to leadcross‑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.

• Deepexpertisein 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.

Alameda, CA

$150,000 to…