Senior Quality Engineer, MedTech - CAPA & Compliance

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

Job summary

Intuitive is a global leader in robotic-assisted surgery seeking a seasoned Quality Engineer to oversee end-to-end quality investigations across the Endoluminal product family. You will manage CAPA, risk assessments, and regulatory compliance with GMP, ISO, and FDA standards.

You will mentor junior engineers, support audits and customer activities, and drive continuous quality improvements through data analysis and cross-functional collaboration.

Qualifications

• Minimum 8 years of experience in QE/QA and a bachelor’s degree in engineering or a relevant discipline.
• At least 2 years of experience in a regulated industry in a relevant discipline.

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 as listed: 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.

Skills

Quality Engineering

Regulated industry

NPI support

Data analysis

Cross-functional collaboration

Leadership

Education

Bachelor’s degree in Engineering or relevant discipline

Tools

QA documentation tools

CAPA systems

Job description

Intuitive is a global leader in robotic-assisted surgery seeking a seasoned Quality Engineer to oversee end-to-end quality investigations across the Endoluminal product family. You will manage CAPA, risk assessments, and regulatory compliance with GMP, ISO, and FDA standards.

You will mentor junior engineers, support audits and customer activities, and drive continuous quality improvements through data analysis and cross-functional collaboration.