Quality Engineer 3 - Multiport Da Vinci

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Intuitive in Sunnyvale, CA, seeks a QA engineer to own investigations within the Endoluminal family and to drive CAPA and non-conformances. You will ensure test records and reports remain complete and accurate while escalating quality risks as needed.

You will mentor junior QEs, update QMS documentation, and lead risk assessments with cross-functional teams to strengthen product quality and regulatory compliance.

Qualifications

• Bachelor’s degree in a relevant field.
• Experience with GMP, ISO, FDA requirements is preferred.
• Strong investigative and data-analysis skills.

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.
• 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).

Skills

Quality assurance

Investigation leadership

Regulatory compliance

Data analysis

Education

Bachelor's degree in Engineering or Life Sciences

Tools

CAPA software

Excel

Job description

Job Description

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