Senior Quality Engineer - Endoluminal Product Owner

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 170,000; Full time

Job summary

Intuitive is seeking a Quality Engineer to independently own quality initiatives across the Endoluminal product family, spanning design, manufacturing and service. You will lead investigations, CAPA efforts, risk assessments, and data-driven reviews to ensure compliance with GMP, ISO, and FDA standards.

You will collaborate with cross-functional teams, mentor others, and drive continuous improvement through core project participation and robust QMS updates.

Qualifications

• Independently owns product, process and complaint investigations within the Endoluminal product family.
• Serves as escalation owner for low to medium impact product quality risks.
• Review and maintain test records and reports for completeness and accuracy.
• Own, drive and/or participate in CAPA and systemic Process non-conformances.
• Assist in updating and revising QMS documentation.
• Leads risk assessment activities and process reviews.
• Analyze and present data for trends in defects and report out to peers at an established cadence.
• Ensure compliance with company and regulatory standards (GMP, ISO, FDA).
• Be an integral member of a project Core Team and contribute meaningfully to the project’s success.
• Communicate findings and recommendations to stakeholders.
• Ownership of continuous improvement projects with various levels of scope (Business Unit/Org/Team).

Responsibilities

• Independently owns product, process and complaint investigations within the Endoluminal product family.
• Serves as escalation owner for low to medium impact product quality risks.
• Review and maintain test records and reports for completeness and accuracy.
• Own, drive and/or participate in CAPA and systemic Process non-conformances.
• Assist in updating and revising QMS documentation.
• Leads risk assessment activities and process reviews.
• Analyze and present data for trends in defects and report out to peers at an established cadence.
• Ensure compliance with GMP, ISO, FDA standards.
• Be an integral member of a project Core Team and contribute to project success.

Skills

Quality Assurance

CAPA

Risk Assessment

Data Analysis

Complaint Investigations

Quality Systems

Job description

Intuitive is seeking a Quality Engineer to independently own quality initiatives across the Endoluminal product family, spanning design, manufacturing and service. You will lead investigations, CAPA efforts, risk assessments, and data-driven reviews to ensure compliance with GMP, ISO, and FDA standards.

You will collaborate with cross-functional teams, mentor others, and drive continuous improvement through core project participation and robust QMS updates.