Senior Quality Engineer, Endoluminal Systems

Intuitive; California (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Intuitive is seeking an experienced Quality Engineer to own end-to-end investigations across manufacturing, supplier, design, and customer complaint domains. The role drives CAPA, risk assessment, and regulatory compliance, mentoring junior staff and influencing cross-functional teams.

The candidate will support audits, analyze KPI trends, and lead continuous improvement within the Endoluminal product family and related processes, ensuring GMP, ISO, and FDA standards are met.

Qualifications

• 8+ years in QE/QA with an engineering degree.
• Minimum 2 years in a regulated industry.

Responsibilities

• Oversees end-to-end quality investigations across operations, design, and customer complaints.
• Leads audits and identifies systemic quality issues with sustainable solutions.
• Owns CAPA and process NCs; mentors junior engineers.
• Supports regulatory and customer audits and responses.
• Analyzes advanced quality data and KPI trends; drives risk management.

Skills

QE/QA

Regulated industry

NPI

Electro-mechanical

Inspection design

Quality principles

Data analysis

Issue resolution

Cross-functional collaboration

Education

Bachelor's degree in engineering

Job description

Intuitive is seeking an experienced Quality Engineer to own end-to-end investigations across manufacturing, supplier, design, and customer complaint domains. The role drives CAPA, risk assessment, and regulatory compliance, mentoring junior staff and influencing cross-functional teams.

The candidate will support audits, analyze KPI trends, and lead continuous improvement within the Endoluminal product family and related processes, ensuring GMP, ISO, and FDA standards are met.