Senior Quality Engineer - Medical Devices & Robotics

Intuitive; California (MO); On-site; USD 110,000 - 160,000; Full time

Job summary

Intuitive is seeking an experienced Quality Engineer for end-to-end investigations across manufacturing, supplier, and design activities. You will drive risk assessment, CAPA, and QMS improvements to sustain patient safety and product quality.

The role requires navigating regulatory standards (GMP/ISO/FDA) while mentoring junior staff and collaborating with cross-functional teams to implement robust quality improvements.

Qualifications

• Minimum 8 years of QE/QA experience with a bachelor's degree in engineering or a related field.
• At least 2 years of experience in a regulated industry.
• Experience supporting NPI from design through manufacturing transfer.
• Strong data analysis, problem solving and cross-functional leadership.

Responsibilities

• Lead critical product and process investigations with cross-site impact.
• Own CAPA and process NCs, drive corrective actions.
• Mentor junior engineers and technicians in quality practices.
• Support regulatory and customer audits and responses.
• Analyze quality data trends and ensure GMP/ISO/FDA compliance.

Skills

QA/QA

Regulated industry

NPI support

Data analysis

CAPA

Cross-functional collaboration

Quality systems

Mentoring

Education

Bachelor's in engineering or relevant discipline

Job description

Intuitive is seeking an experienced Quality Engineer for end-to-end investigations across manufacturing, supplier, and design activities. You will drive risk assessment, CAPA, and QMS improvements to sustain patient safety and product quality.

The role requires navigating regulatory standards (GMP/ISO/FDA) while mentoring junior staff and collaborating with cross-functional teams to implement robust quality improvements.