Principal Quality Engineer

General Summary

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

This role requiresstructured Quality Engineering approaches,strongengineeringanalysis and methodologies, statisticalexperience, and the ability to architect scalable

Quality

Engineeringsystems that prevent defects, reduce variation, and enhancelong-termmanufacturing robustness. You will influence quality strategy, develop new approachsto systemic quality challenges, and champion a culture of operational excellence across the organization.

Workingcross-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.

Specific Duties and Responsibilities

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

• Identify, quantify, and prioritize systemic quality improvement opportunities usingdata-drivenmethods, advanced analytics, and structured problem-solvingframeworks.

• 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-complexityproblem-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-basedacceptance strategies.

• Champion Lean, Six Sigma, and operational excellence methodologies, setting direction for waste reduction, variation control, and process robustness.

• Influencelong-termquality 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.

Position Qualifications

• 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-scalecontinuous 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.

Preferred Experience

• 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-termquality strategy.

Location: Alameda, CA

Salary: $150,000 to $195,000

Working Conditions:

• General office, laboratory, and cleanroom environments

• Business travel from 0% – 10%

• Potential exposure to blood borne pathogens

• Requires lifting and moving up to 25 pounds

• Must be ableto move between buildings and floors

• Must be ableto remain stationary and use standard office equipment for extended periods

• Mustbe ableto read, prepare emails, and produce documents and spreadsheets

• Must be ableto move within…