IntuitiveCompliance & Validation Manager
Company Description
It started with a simple idea: what if surgery could be less invasive and recovery less painful? Nearly 30 years later, that question still fuels everything we do at Intuitive. As a global leader in robotic-assisted surgery and minimally invasive care, our technologies—like the da Vinci surgical system and Ion—have transformed how care is delivered for millions of patients worldwide.
We’re a team of engineers, clinicians, and innovators united by one purpose: to make surgery smarter, safer, and more human. Every day, our work helps care teams perform with greater precision and patients recover faster, improving outcomes around the world.
The problems we solve demand creativity, rigor, and collaboration. The work is challenging, but deeply meaningful—because every improvement we make has the potential to change a life.
If you’re ready to contribute to something bigger than yourself and help transform the future of healthcare, you’ll find your purpose here.
Job Description
Job Summary:The West Compliance and Validation Manager is responsible for ensuring that the RealEstate and Workplace Services (REWS) group and related company operations complywith industry standards, and regulatory requirements.The role oversees internal and external audits and manages compliance related risk. Therole will develop and validate company policies and operational processes. Additionally,the role will manage related vendors deliverables across multiple sites and regions.The ideal candidate will have a strong understanding of compliance frameworks, qualityassurance, contract and vendor management, and facilities regulatory standards withinFacilities and Construction focused Medical Device industry.
Key Responsibilities:
Compliance Oversight:• Monitor compliance with internal policies, regulatory requirements, and industrybest practices.• Develop, maintain, and enforce compliance programs and policies across REWSoperations.• Coordinate internal and external audits, inspections and assessments.• Track findings and corrective actions to closure.• Ensure documentation is maintained and updated in accordance with regulatoryand company standards.
Validation & Quality Assurance:• Validate new facility systems, workplace technology implementations, andprocesses to ensure quality, compliance, and performance.• Work with Construction partners to review and approve facility commissioning,HVAC systems, cleanroom validations (if applicable), and systems validation & lifecycle.• Develop and manage documentation protocols, including validation plans andprotocols (CC, RAs, IQ/OQ/PQ), deviation reports, and final summary reports.
Vendor and Contractor Compliance:• Evaluate and monitor service providers, contractors, and partners to ensureadherence to contractual obligations, company standards, and regulatoryrequirements.• Perform compliance-relevant reviews during RFP/RFQ phases, vendoronboarding, and operational performance.
Risk Management:• Identify compliance risks and proactively implement mitigation strategies.• Conduct root cause analysis and lead resolution planning for non-conformanceevents.• Maintain a risk register for facility operations and real estate developmentactivities.
Training and Awareness:• Design and deliver compliance and validation training programs for internalteams and external vendors.• Promote a culture of quality, integrity, safety, and continuous improvementthroughout workplace operations.
Reporting & Communication:• Provide regular updates and reports to leadership regarding compliance status,audit outcomes, and risk assessments.• Liaise with stakeholders (Quality, Manufacturing, Engineering, Safety Securityand Resilience, Legal, Finance, and IT departments) to ensure cross-functionalcompliance alignment.
Qualifications
Required Qualifications:• Bachelor’s degree in Engineering, Quality Management, or comparable workexperience.• 5–8 years of experience in a compliance, validation, or quality assurance rolewithin Operations, Quality, Facilities, or workplace services within Life Sciencesand Regulated Industries.• Strong knowledge of regulatory frameworks; QMS, qualification, validation, ISOstandards (e.g. ISO 13485, 14001), FDA & EU regulations, and local & regionalcodes.• Experience with commissioning, qualification & validation protocols (IQ/OQ/PQ),medical cleanrooms and building management systems.• Excellent analytical, organizational, and communication skills.• Proven experience in managing third-party vendors and compliance audits
Preferred Qualifications:• Experience in highly regulated industries such as Biotech, Medical Devicesmanufacturing, healthcare, or finance.• Familiarity with computerized maintenance management systems (CMMS) andintegrated workplace management systems (IWMS).
• Experience with Agile, Neptune, and Trackwise highly desired.• Master’s degree or MBA is a plus.• Professional certifications (e.g., TEXT).
Work Environment:• Office-based up to 25% travel to regional and international sites.• May require presence on construction sites, active facilities, or industriallocations.
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.
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.
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.