Compliance & Validation Manager

Intuitive•Sunnyvale, CA

About The Position

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 Summary: The West Compliance and Validation Manager is responsible for ensuring that the Real Estate and Workplace Services (REWS) group and related company operations comply with industry standards, and regulatory requirements. The role oversees internal and external audits and manages compliance related risk. The role 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, quality assurance, contract and vendor management, and facilities regulatory standards within Facilities and Construction focused Medical Device industry.

Requirements

Bachelor’s degree in Engineering, Quality Management, or comparable work experience.
5–8 years of experience in a compliance, validation, or quality assurance role within Operations, Quality, Facilities, or workplace services within Life Sciences and Regulated Industries.
Strong knowledge of regulatory frameworks; QMS, qualification, validation, ISO standards (e.g. ISO 13485, 14001), FDA & EU regulations, and local & regional codes.
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

Nice To Haves

Experience in highly regulated industries such as Biotech, Medical Devices manufacturing, healthcare, or finance.
Familiarity with computerized maintenance management systems (CMMS) and integrated 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).

Responsibilities

Compliance Oversight: Monitor compliance with internal policies, regulatory requirements, and industry best practices.
Develop, maintain, and enforce compliance programs and policies across REWS operations.
Coordinate internal and external audits, inspections and assessments.
Track findings and corrective actions to closure.
Ensure documentation is maintained and updated in accordance with regulatory and company standards.
Validation & Quality Assurance: Validate new facility systems, workplace technology implementations, and processes 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 & life cycle.
Develop and manage documentation protocols, including validation plans and protocols (CC, RAs, IQ/OQ/PQ), deviation reports, and final summary reports.
Vendor and Contractor Compliance: Evaluate and monitor service providers, contractors, and partners to ensure adherence to contractual obligations, company standards, and regulatory requirements.
Perform compliance-relevant reviews during RFP/RFQ phases, vendor onboarding, and operational performance.
Risk Management: Identify compliance risks and proactively implement mitigation strategies.
Conduct root cause analysis and lead resolution planning for non-conformance events.
Maintain a risk register for facility operations and real estate development activities.
Training and Awareness: Design and deliver compliance and validation training programs for internal teams and external vendors.
Promote a culture of quality, integrity, safety, and continuous improvement throughout 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 Security and Resilience, Legal, Finance, and IT departments) to ensure cross-functional compliance alignment.