Quality Engineer – Medical Devices & Continuous Improvement

Intuitive; California (MO); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Market-competitive compensation

Job summary

Intuitive seeks a Quality Engineer who will own quality investigations within the Endoluminal product family, driving CAPAs and improvements across design, manufacturing, and service. You will review records, analyze defect trends, and ensure regulatory compliance in a cross-functional team.

The role requires at least 5 years in QE/QA with a engineering degree, strong data skills, and excellent collaboration. Travel is limited; a competitive compensation package awaits the right candidate.

Qualifications

• Bachelor’s degree in engineering or relevant discipline with at least 5 years of QE/QA experience.
• Solid understanding of quality principles and methodologies.
• Strong data analysis and interpretation skills.
• Excellent communication and teamwork abilities.

Responsibilities

• Own product, process and complaint investigations within Endoluminal product family.
• Serve as escalation owner for low to medium impact quality risks.
• Review and maintain test records and reports for completeness and accuracy.
• Lead CAPA and systemic process non-conformances.
• Assist in updating and revising QMS documentation.
• Lead risk assessment activities and process reviews.
• Analyze data for defects trends and report to peers on cadence.
• Ensure compliance with GMP, ISO, FDA standards.
• Be an integral member of a project Core Team and contribute to success.
• Communicate findings and recommendations to stakeholders.
• Drive continuous improvement projects across various scopes.

Skills

Quality principles

Data analysis

Independent issue resolution

Communication and teamwork

Regulatory knowledge

Education

Bachelor’s degree in engineering or relevant discipline

Job description

Intuitive seeks a Quality Engineer who will own quality investigations within the Endoluminal product family, driving CAPAs and improvements across design, manufacturing, and service. You will review records, analyze defect trends, and ensure regulatory compliance in a cross-functional team.

The role requires at least 5 years in QE/QA with a engineering degree, strong data skills, and excellent collaboration. Travel is limited; a competitive compensation package awaits the right candidate.