QA Engineer, Medical Devices Manufacturing

Regulatory Jobs; Yorba Linda (CA); On-site; USD 105,000 - 129,000; Full time

Job summary

Nobel Biocare is seeking a Quality Assurance Engineer to ensure production processes stay in control, with robust validation and verification activities to consistently meet specifications for medical devices. You will support NPI and lifecycle management while driving continuous improvement across manufacturing and QA processes.

The role requires 6+ years in quality engineering within regulated manufacturing, strong root cause analysis and PFMEA experience, and fluency in English.

Qualifications

• Bachelor's degree in Engineering, Life Sciences or related disciplines.
• 6+ years of quality engineering experience in medical devices or regulated manufacturing.
• Hands-on expertise in root cause analysis tools (5-Why, Fishbone, Lean or Six Sigma).
• Experience with risk management tools (PFMEA).
• Fluency in English.

Responsibilities

• Support translation of process risk into PFMEA controls and standard work.
• Ensure validations and verifications are robust and oversee revalidation cycles.
• Ensure manufacturing procedures are strictly applied.
• Partner with manufacturing engineering to optimize inspection and testing methods.
• Participate in NPI and Lifecycle projects to ensure compliant execution.
• Document, evaluate and track production non-conformances and lead CAPA actions.
• Use data to detect variation, confirm capability and drive improvements.
• Support audits and regulatory compliance activities.
• Assist in creation and improvement of QA processes.

Skills

Root cause analysis

5-Why

Fishbone

Lean

Six Sigma

PFMEA

Education

Bachelor's degree in Engineering/Life Sciences

Tools

PFMEA

Job description

Nobel Biocare is seeking a Quality Assurance Engineer to ensure production processes stay in control, with robust validation and verification activities to consistently meet specifications for medical devices. You will support NPI and lifecycle management while driving continuous improvement across manufacturing and QA processes.

The role requires 6+ years in quality engineering within regulated manufacturing, strong root cause analysis and PFMEA experience, and fluency in English.