Principal Quality Engineer

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

Job summary

Doist is seeking a Principal Quality Engineer to act as a technical leader across Operations, strengthening process capability and implementing scalable quality systems. You will guide data-driven improvements, design predictive analytics, and champion Lean Six Sigma methodologies to reduce defects and variation.

You will collaborate with Manufacturing Engineering, Industrial Engineering, Operations Leadership, and R&D to ensure quality is designed into processes and risks are mitigated with

Qualifications

• Bachelor’s degree in Engineering; advanced degree preferred.
• 7+ years of experience in Quality Engineering, Continuous Improvement, or Manufacturing Engineering in medical device manufacturing.
• Experience with Lean Six Sigma and CTQ deployment programs.
• Expert understanding of FDA QSR and ISO 13485 in manufacturing.
• ASQ CQE, CSSBB, or equivalent advanced quality certification.
• Strong data analysis, statistical modeling, and decision-making skills.
• Experience implementing automation and digital quality systems.

Responsibilities

• Lead cross-functional continuous improvement initiatives to reduce Cost of Poor Quality.
• Identify, quantify, and prioritize systemic quality improvement opportunities using data-driven methods.
• Own complex NCRs and CAPAs, and participate in NCR boards.
• Develop and deploy CTQ flowdowns aligning product requirements with process controls.
• Architect and optimize quality monitoring systems including predictive analytics and SPC.
• Lead high-complexity problem-solving using DOE, regression modeling, and multivariate analysis.
• Drive continuous improvement of inspection systems and measurement capability.
• Champion Lean, Six Sigma, and operational excellence methodologies.
• Influence long-term quality strategy including digital quality transformation.
• Train and mentor Quality Engineers to elevate technical capability.

Skills

Advanced data analysis

Statistical modeling

DOE

Regression modeling

Multivariate analysis

Cross-functional collaboration

Education

Bachelor’s degree in Engineering

Advanced degree preferred

Tools

Measurement system analysis

Destructive testing

Job description

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.
• 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.
• 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.
• 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

Roseville, CA

Annual Base Salary Range

$135,000 to $175,000

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