Compliance Specialist

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.

Essential Job Duties

• 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.

Qualifications :

Required Skills and Experience

• 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.

Required Education and Training

• Typically requires a minimum of 5 years of related experience with a university degree; or 3 years with a Masters degree; or equivalent demonstrated experience.

• 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.

Preferred Skills and Experience

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

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.

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 employeeswho 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 governments 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 employeesstart 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.

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidates experience knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidates qualifications consistent with applicable law.

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.

Remote Work :

No

Employment Type :

Full-time