Staff Quality System Engineer

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

• Bachelors 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 employeeswho 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 governments 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 employeesstart 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 candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates 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.

Remote Work :

No

Employment Type :

Full-time