Staff Quality System Engineer

Staff Quality System 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.

We're a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.

The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful-because every improvement we make has the potential to change a life.

If you're ready to contribute to something bigger than yourself and help transform the future of healthcare
, you'll find your purpose here.

Principal-level professional individual contributor leading enterprise-wide or global compliance initiatives. Drives policy, major risk assessments, remediation projects, compliance strategy, audit response, training programs, technology adoption, and business integration activities. Represents the organization in regulatory, client, industry, or executive interactions.

• Develop, implement, and harmonize compliance programs, policies, and QMS controls company-wide or globally.
• Lead major risk assessments, gap assessments, company investigations, remediation projects, and CAPA-related compliance programs.
• Guide responses to high-profile regulatory audits, inspections, client reviews, and industry assessments.
• Advise executives on compliance risks, regulatory trends, business impact, and company strategy.
• Lead compliance training initiatives and develop core certification programs.
• Mentor and coach senior compliance specialists.
• Oversee compliance technology adoption and digital transformation.
• Align compliance operations with business performance and industry benchmarks.
• Represent the organization at external forums, industry events, and regulatory agencies.
• Lead post-merger, expansion, and business integration compliance due diligence.

• Minimum 12 years of compliance, quality systems, or regulatory program experience, or equivalent combination of education and experience.
• Deep expertise in global or regional regulations and quality system requirements relevant to the business.
• Demonstrated experience leading enterprise or global compliance programs, major risk assessments, remediation projects, audit responses, investigations, and cross-functional initiatives.
• Mastery in strategic planning, policy writing, enterprise risk management, audit management, and regulatory interface activities.
• Strong executive communication, training, talent development, change leadership, and program management capabilities.
• Ability to influence senior leaders and represent the company in regulatory, client, or industry interactions.

• Bachelor's degree in a relevant field, or equivalent combination of education and experience.
• Advanced degree preferred.
• Training or certification in quality systems, auditing, enterprise risk management, regulatory compliance, project management, change leadership, or compliance program management preferred.

• Office or hybrid work environment.
• Frequent interaction with executives, process owners, auditors, regulators, clients, industry representatives, and cross-functional teams.
• Work may involve high-priority compliance issues, regulatory inspections, major remediation programs, and complex implementation schedules.
• Requires the ability to support global teams, business needs, and time-sensitive compliance commitments across time zones.
• Domestic and international travel required.

• Experience leading enterprise QMS programs, global compliance harmonization, regulatory remediation, Class II or Class III medical device…