Quality Engineer - Endoluminal Systems & CAPA Leader

Intuitive; Sunnyvale (CA); On-site; USD 127,000 - 183,000; Full time

Job summary

Intuitive is seeking a Senior QE professional to independently own quality projects within the Endoluminal product platform. You will drive investigations, CAPA activities, and process improvements across design, manufacturing, and service.

Responsibilities include leading risk assessments, maintaining QA documents, and communicating findings to stakeholders. Strong data analysis and regulatory knowledge are essential for success in this onsite role.

Qualifications

• Minimum 5 years of QE/QA experience.
• Bachelor’s degree in engineering or related discipline.
• Strong data analysis and quality methodologies.

Responsibilities

• Own product, process and complaint investigations within Endoluminal family.
• Escalation owner for low to medium impact quality risks.
• Review and maintain test records and reports for completeness/accuracy.
• Lead CAPA and systemic non-conformances.
• Update and revise QMS documentation.
• Lead risk assessments and process reviews.
• Analyze data for trends in defects and report findings.

Skills

Quality principles

Data analysis

Issue identification

Communication

Regulatory awareness

Education

Bachelor’s degree in engineering

Job description

Intuitive is seeking a Senior QE professional to independently own quality projects within the Endoluminal product platform. You will drive investigations, CAPA activities, and process improvements across design, manufacturing, and service.

Responsibilities include leading risk assessments, maintaining QA documents, and communicating findings to stakeholders. Strong data analysis and regulatory knowledge are essential for success in this onsite role.