Sr. Quality System Engineer

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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. 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 Bachelor's 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. 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 instruc

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