Staff Quality System Engineer

Job Description

Primary Function of Position

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.

Essential Job Duties

• 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.

Qualifications

Required Skills and Experience

• 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.

Required Education and Training

• 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.

Working Conditions

• 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.

Preferred Skills and Experience 

• Experience leading enterprise QMS programs, global compliance harmonization, regulatory remediation, Class II or Class III medical device compliance, IVD or IVDR, post-merger integration, digital compliance transformation, regulatory agency interactions, and executive governance forums.
• Advanced certifications such as ASQ CQA, CQE, CMQ/OE, RAC, Lean Six Sigma Black Belt, PMP, or enterprise risk management certification preferred.
• Experience influencing executive leadership and representing the company externally preferred.

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 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.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.

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 compensation ranges are listed.

Min. Salary Region 1: 182900 USD
Min. Salary Region 2: 155500 USD
Max. Salary Region 2: 223600 USD
Max. Salary Region 1: 263100 USD