Senior Quality Engineer

Intuitive Surgical, Inc. in; Sunnyvale (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

Intuitive Surgical is seeking a Senior Quality Engineer to oversee end-to-end quality investigations across design, manufacturing and supplier operations within the Endoluminal product family. You will lead cross-functional teams, drive CAPAs, and ensure regulatory compliance.

The role emphasizes data-driven improvements, risk assessment, and mentoring junior engineers, with a focus on detecting issues early and preventing recurrence while coordinating audits and quality documentation.

Qualifications

• Minimum 8 years of QE/QA experience.
• Bachelor's degree in engineering or related discipline.
• At least 2 years of experience in a regulated industry.

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.
• Supports 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 GMP, ISO, FDA.
• Drive and own CAPA and/or Process NCs.

Skills

NPI experience

Mechanical assembly

Inspection design

Quality principles

Data analysis

Issue resolution

Cross-functional communication

Education

Bachelor's degree in engineering or related discipline

2+ years regulated industry experience

Job description

Senior Quality Engineer (Finance)

Company Description

It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies-like the da Vinci surgical system and Ion-have transformed how care is delivered for millions of patients worldwide.

Job Description

Primary Function of Position

This role oversees end-to-end quality investigations (spanning on-site manufacturing operations, supplier operations, product design activities and customer complaints), risk management, new product development and BU wide improvement initiatives across the Endoluminal product family and operational area.

Essential Job Duties

• 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

Qualifications

Required Experience and Education

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

Required Knowledge, Skills and Abilities

• Experience in supporting NPI from design and development through to manufacturing transfer
• Demonstrated experience supporting mechanical assembly of electro-mechanical systems, including supporting multi-component assembly processes.
• Skilled in designing and implementing inspection at upstream and downstream stages to early and appropriate detection
• Strong understanding of quality principles and methodologies
• Strong data analysis and data interpretation skills
• Strong ability to drive and resolve quality issues
• Strong communication and team collaboration, ability to influence stakeholders across departments

Physical Requirements

• Office, lab, production, and site travel as needed (<10)
• Frequent computer and inspection work.
• Occasional lifting (<25)

Additional Information

Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19. Details can vary by role.

Intuitive is an Equal Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

Mandatory Notices

U.S. Export Controls Disclaimer: In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government's licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan ("TCP") (note: typically adds 2 weeks to the hiring process).

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee's start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes.

We will consider for employment qualified applicants with