Quality Engineer 3 - Endoluminal Systems

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

Job Description

Primary Function of Position

This role independently owns quality projects and initiatives, investigations, inspections and improvement activities within the Endoluminal product platform. The role will span design, manufacturing and service of a selected product or sub-system.

Essential Job Duties

• 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)

Breadth of Impact and Leadership

• 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