Sr. Quality System Engineer

Primary Function of Position

Senior professional individual contributor leading complex QMS compliance initiatives policy implementation risk assessments remediation actions audit readiness and cross-functional quality system projects. Provides technical leadership and supports alignment across functions sites regions and business units.

Essential Job Duties

• Lead complex QMS compliance projects risk assessments remediation plans policy implementation and quality plan execution across functions or sites.

• Define implementation approach deliverables governance risks success criteria and escalation pathways.

• Provide senior-level review of QMS changes procedures training plans records dashboards and implementation evidence.

• Lead cross-functional meetings align stakeholders remove barriers and drive action closure.

• Mentor junior specialists and provide technical guidance on QMS compliance execution.

• Support regulatory inspections notified body audits industry reviews client reviews and executive updates.

• Drive process standardization compliance technology adoption digital workflow improvements and continuous improvement.

Qualifications :

Required Skills and Experience

• 6 to 10 years of experience in Quality Systems Compliance Regulatory Engineering Operations or a related field.

• Strong knowledge of medical device QMS requirements and regulated change implementation.

• Experience leading cross-functional QMS projects policy implementation risk assessments remediation activities audit readiness or inspection support.

• Strong technical writing risk-based thinking stakeholder management executive communication and project leadership skills.

• Ability to coach junior team members and influence cross-functional teams without direct authority.

• Ability to translate regulatory and procedural requirements into practical implementation plans.

Required Education and Training

• Bachelors degree in engineering Life Sciences Quality Regulatory Affairs Compliance or related discipline.

• Equivalent combination of education and relevant experience may be considered.

• Advanced degree or professional certification preferred.

• Training in medical device QMS requirements quality planning audit support risk management project leadership remediation management and Good Documentation Practices required.

Working Conditions

• Office or hybrid work environment.

• Frequent cross-functional engagement across sites regions business units and process ownership teams.

• Work may include time-sensitive deliverables audit readiness support inspection response remediation tracking and leadership reporting.

• Requires the ability to manage multiple priorities and support business needs across time zones.

• Domestic or international travel may be required to support inspections projects site readiness or implementation.

Preferred Skills and Experience 

• Experience leading quality plans QMS remediation policy implementation regulatory inspection readiness process standardization compliance technology implementation or multi-site QMS deployment.

• Certifications such as ASQ CQA CQE CMQ/OE RAC Lean Six Sigma or PMP preferred.

• Experience mentoring junior staff and preparing executive-level compliance updates 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