Compliance Specialist

Intuitive • Sunnyvale, CA

2d

About The 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.

Requirements

• Working knowledge of 21 CFR Part 820, ISO 13485:2016, and EU MDR 2017/745 as applicable to supplier, service supplier, and distributor controls.
• Familiarity with ISO 17025, ISO 11135/11137, and GDP/GMP requirements for service and distribution suppliers.
• Proficiency with QMS platforms including Trackwise, SAP, Coupa and Agile for supplier file management, SCAR tracking, and audit scheduling.
• Proficiency with MS Office suite; working knowledge of basic AI prompts.
• Ability to work effectively within cross-functional and global teams under direction of senior staff.
• Good written, verbal, and presentation communication skills; comfortable presenting audit findings and compliance data to peers and supervisors.
• Developing judgment in implementing practical QMS solutions within established regulatory frameworks.
• Analytical problem-solving skills and genuine interest in quality systems within complex, technology-driven industries.
• BS/BA degree in Engineering, Life Sciences, or a related technical discipline preferred.
• Experience working in a regulated medical device or life sciences manufacturing environment required.

Nice To Haves

• Exposure to auditing service suppliers and/or distributors in a medical device setting.

Responsibilities

• Execute assigned audit program activities within a risk-stratified audit program covering direct material suppliers, service suppliers (e.g., 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 Requisitions 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 820.130, ISO 13485 clause 7.5.5, 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 supplier and distributor files in Trackwise and SAP, including audit records, ISO certifications, conditional approval documentation, and ARFs.
• Support resolution of Process Nonconformances (NCs) and CAPAs related to supply chain audit and controls processes under the direction of senior compliance staff.
• Collaborate with IT and senior team members to support enhancements to QMS platforms (Trackwise, SAP, Agile) used in supply chain audit workflows.
• Participate in FDA inspections, Notified Body audits (e.g., BSI, TÜV), and internal audits as a supporting team member for Supplier Controls, Service Supplier qualification, and Distributor Controls.
• Manages assigned tasks and priorities with moderate oversight in a fast-paced, regulated environment.

Benefits

• market-competitive compensation packages, inclusive of base pay, incentives, benefits, and equity

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level