Lead Quality Engineer – Medical Devices & Analytics

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

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