Jobs in Roseville, CA

About the role

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.

What you'll bring

• Bachelor’s degree in Engineering
• 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.
• Ability to thrive in a dynamic, fast‑paced environment while influencing long‑term quality strategy.
• Biomedical, Mechanical, Materials, Chemical, or related discipline preferred
• advanced degree strongly preferred.

Benefits