General Summary 

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

This role requires structured Quality Engineering approaches, strong engineering analysis 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 are identified and executed with rigor. 

Specific Duties and Responsibilities 

• 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. 

• 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. 

• 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. 

Position 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. 

• 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. 

Preferred Experience 

• 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. 

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 bloodborne pathogens 

• Requires lifting and moving up to 25 pounds 

• Must be able to move between buildings and floors 

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

• Must be able to read, prepare emails, and produce documents and spreadsheets 

• Must be able to move within the office and access files or supplies as needed 

• Must be able to communicate and exchange accurate information with employees at all levels