QA Engineering Mgmt 3 (Finance)

Company Description
At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints.

As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare's hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

Passionate people who want to make a difference drive our culture. Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential.

Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together, let's advance the world of minimally invasive care.
Job Description
Position Summary:

We are seeking a highly motivated and experienced Quality Engineering Manager to lead and support quality engineering activities for the development, manufacturing, and post-market support of medical devices. The ideal candidate will ensure products are designed and manufactured in compliance with FDA 21 CFR Part 820, ISO 13485, and applicable regulatory requirements. This role is critical to maintaining product quality, patient safety, and regulatory compliance across the product lifecycle.

Key Responsibilities:

• Lead and manage a team of Quality Engineers responsible for design assurance, process, product and equipment validation, risk management, and CAPA.
• Provide quality engineering support throughout the product lifecycle, from concept through commercialization and post-market activities.
• Lead risk management activities per ISO 14971, including FMEAs and fault tree analysis.
• Oversee design control documentation and support DHF reviews to ensure regulatory compliance.
• Develop and implement process validation protocols (IQ/OQ/PQ) for new and existing manufacturing processes.
• Partner with R&D, Manufacturing, Regulatory Affairs, and other cross-functional teams to support product development and sustaining engineering efforts.
• Drive root cause analysis and corrective/preventive actions (CAPA) for product and process nonconformances.
• Participate in internal and external audits (FDA, ISO, MDSAP), including preparation and response.
• Establish and report on quality metrics/KPIs; monitor trends and recommend improvements.
• Provide training and mentorship to the quality engineering team and broader organization on quality standards and best practices.

Qualifications
Required Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or related technical discipline; advanced degree preferred.
• 7+ years of experience in quality engineering or quality assurance in a medical device or regulated industry.
• 2-4 years of experience in a supervisory or managerial role.
• In-depth knowledge of ISO 13485, FDA QSR (21 CFR Part 820), and risk management principles (ISO 14971).
• Strong background in design control, product verification/validation, and process validation.
• Proficiency in quality tools such as root cause analysis, FMEA, SPC, and statistical analysis.
• Excellent communication, project management, and leadership skills.

Preferred Qualifications:

• Certified Quality Engineer (CQE), Six Sigma Black Belt, or similar certification.
• Experience with software as a medical device (SaMD) or combination products.
• Working knowledge of EU MDR and global regulatory requirements.

Working Conditions:

• Office and occasional cleanroom/manufacturing environment.
• Occasional travel may be required (

Why Join Us?

• Work with innovative products that improve lives.
• Collaborative and growth-oriented team culture.
• Competitive salary, bonus structure, and benefits package.

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

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.

Preference will be given to qualified candidates who do not reside, or plan to reside, in Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, or Tennessee.

We provide market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity. It would not be typical for someone to be hired at the top end of range for the role, as actual pay will be determined based on several factors, including experience, skills, and qualifications. The target salary ranges are listed.

Base Salary Range Region 1: $156,000 USD - $224,400 USD
Base Salary Range Region 2: $132,600 USD - $190,800 USD
Shift: Day
Workplace Type: Onsite - This job is fully onsite.