Quality Engineer – Endoluminal Systems & CAPA Lead

Intuitive; Sunnyvale (CA); On-site; USD 110,000 - 170,000; Full time

Job summary

Intuitive is seeking a Quality Engineer to independently own product, process and complaint investigations within the Endoluminal product family. You will serve as escalation owner for low to medium risk issues and drive CAPA and systemic non-conformances.

You will review test records, update QMS documentation, lead risk assessments, analyze defect data and ensure GMP/ISO/FDA compliance. Collaboration across a project Core Team is essential to drive continuous improvement and successful outcomes.

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 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)
• Owns quality outcomes for a product or defined subsystem.
• Recognized as a reliable QE partner by cross-functional product team.
• May mentor/coach junior level QEs on tools, processes and investigations.
• Leads small initiatives

Job description

Intuitive is seeking a Quality Engineer to independently own product, process and complaint investigations within the Endoluminal product family. You will serve as escalation owner for low to medium risk issues and drive CAPA and systemic non-conformances.

You will review test records, update QMS documentation, lead risk assessments, analyze defect data and ensure GMP/ISO/FDA compliance. Collaboration across a project Core Team is essential to drive continuous improvement and successful outcomes.