Compliance Specialist, Quality Assurance - QA​/QC

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.

Primary Function of Position

The Compliance Specialist 3 – Supply Chain Audits executes audit and compliance activities across the supply chain ecosystem under general supervision, reporting to the Director, Global Supply Chain Audits. This role supports the technical execution of Supplier Controls, Service Supplier Qualification, and Distributor Controls processes in conformance with applicable regulatory standards (21 CFR Part 820, ISO 13485, EU MDR 2017/745). The specialist works within established audit frameworks to perform scheduled audits, maintain supply chain records, and contribute to CAPA resolution and process improvement efforts.

• Execute assigned audit program activities within a risk‑stratified audit program covering direct material suppliers, service suppliers (sterilization, calibration, testing laboratories, contract manufacturers), and distributors.
• Establish audit master schedules, risk assessments, and qualification criteria aligned with regulatory requirements and internal QMS policies.
• Support global harmonization efforts under direction of senior staff, coordinating with regional Intuitive Surgical entities: ISJ, ISK, IS India, IS Aubonne, ISE, ISB, and IST.
• Participate in cross‑functional coordination meetings to support audit execution, document findings, and escalate issues appropriately including Supplier Monitoring Board (SMB) presentations, KPI calculations, presentations to higher management.
• Perform qualification and re‑evaluation audits for service suppliers including sterilization providers, contract test laboratories, 3PL providers, calibration services, and GxP‑relevant IT/software service vendors.
• Apply applicable standards during audits including ISO 17025 (testing/calibration labs), ISO 11135/11137 (sterilization), and relevant 21 CFR Part 820 subpart requirements.
• Assess service supplier controls for data integrity, method validation, traceability, and change notification compliance.
• Review service agreements, quality agreements, and KPIs as part of assigned service supplier audit and re‑evaluation activities.
• Execute Quality Approval of Purchase Requisition s as needed.
• Conduct Metric Reviews for Suppliers and Distributors.
• Support execution of the Distributor Controls program, including distributor qualification, periodic re‑evaluation, monitoring activities, and disqualification processing per 21 CFR Part , ISO 13485 clause , and EU MDR traceability requirements.
• Assist in maintaining the Approved Distributor List (ADL), processing promotions, conditional approvals, and demotions under guidance from senior staff.
• Coordinate with regional RAQA and commercial teams to track distributor corrective actions and monitor resolution progress.
• Support collection and routing of post‑market surveillance (PMS) data from distributor channels into the global QMS.
• Perform day‑to‑day tasks supporting Approved Supplier List (ASL) maintenance, including processing supplier promotions, demotions, and conditional approvals.
• Execute Supplier Corrective Action Request (SCAR) activities including issuance, aging tracking, phase‑gate follow‑up, and closure documentation.
• Maintain…