Endoluminal Quality Lead: Investigations & CAPA

Intuitive; Sunnyvale (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive seeks a Senior Quality Engineer in Sunnyvale to oversee end-to-end quality investigations across manufacturing, supplier, design, and customer areas. You will lead CAPAs, manage risk assessments, and support audits while mentoring junior staff and ensuring GMP, ISO, and FDA compliance.

This role drives cross-functional improvements across the Endoluminal product family and related operations. The position emphasizes data analysis of quality metrics, escalation for high-impact quality

Responsibilities

• Leads critical product, process investigations and audits with cross functional and cross site impact.
• Identifies systemic quality issues and drives sustainable solutions.
• Ownership of quality investigations for complaints and non-conformances.
• Serves as escalation owner for medium to high impact product quality & compliance risks.
• Author, review, and approve QA documentation and protocols.
• Drive and own corrective and preventive action (CAPA) and/or Process NCs.
• Ownership of risk assessment activities and process reviews.
• Support regulatory and customer audit preparations and responses.
• Analyze and interpret advanced quality data and KPI trends.
• Mentor junior engineers and technicians in technical expertise.
• Ensure compliance with company and regulatory standards (GMP, ISO, FDA).
• Advise cross-functional teams on quality requirements.
• Indentification and ownership of continuous improvement projects.
• Breadth of Impact and Leadership: Owns quality outcomes across a product family, plant, or major operational area; Drives improvements that impact multiple teams or value streams; Leads cross functional teams without authority; Mentor/coach junior QEs to transform into independent owners; Influences decisions through expertise and credibility.

Job description

Intuitive seeks a Senior Quality Engineer in Sunnyvale to oversee end-to-end quality investigations across manufacturing, supplier, design, and customer areas. You will lead CAPAs, manage risk assessments, and support audits while mentoring junior staff and ensuring GMP, ISO, and FDA compliance.

This role drives cross-functional improvements across the Endoluminal product family and related operations. The position emphasizes data analysis of quality metrics, escalation for high-impact quality