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Sr. Quality Systems Engineer

Open 20d

Summary

Oversee compliance and regulatory affairs for a medical-device company, leading audits, risk mitigation, and policy updates to meet evolving healthcare regulations.

Primary Function of Position

This role provides expert oversight of compliance operations for major business units or functional areas, leads high-profile audits, and ensures compliance with complex and evolving regulatory requirements.

Essential Job Duties

  • Lead complex compliance initiatives, risk mitigation, and process improvement programs.
  • Set compliance monitoring schedules and ensure audit readiness.
  • Serve as point of contact for major inspections, agency requests, and customer audits.
  • Review and approve critical compliance documentation and filings.
  • Conduct advanced investigations and develop systemic corrective actions.
  • Advise on regulatory changes and update compliance policies accordingly.
  • Mentor junior compliance team members and deliver advanced training.
  • Present key compliance metrics and trends to leadership.
  • Coordinate company-wide compliance program implementations.
  • Collaborate with legal, HR, and operations for cross-departmental compliance.

Required Experience and Education

  • Minimum 8 years of compliance or regulatory management and bachelor’s degree in a relevant field, or equivalent combination of education and experience

Required Knowledge, Skills and Abilities

  • Advanced expertise in compliance strategy, regulatory affairs, and standards.
  • Leadership in audits, risk management, and policy development.
  • Project, talent, and change management experience.
  • Excellent written and oral communication.
  • Strategic thinking and cross-functional influence.

Physical Requirements

  • Travel required up to 50% of the time

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.

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