Staff Supplier Quality Engineer - ISO 13485 Lead Auditor - Remote from USA
Intuitive · Full-time · Posted 1d ago
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 Staff Supplier Quality Engineer operates with a high degree of independence to determine methodologies, audit frameworks, quality systems, and procedural controls across the global supply chain ecosystem, reporting to the Director, Global Supply Chain Audits.
This role is responsible for the technical execution, continuous improvement, strategic projects, and global harmonization of Third-Party Logistics (3PL) quality management, distribution center controls, and service supplier qualification processes worldwide. The Staff SQE leads risk-based lead audit programs, ensures conformance to applicable global regulatory standards (21 CFR Part 820, ISO 13485, EU MDR 2017/745, Good Distribution Practice / GDP), and serves as a subject matter expert (SME) in regulatory body inspections. S/he partners with cross-functional global operations, logistics, and regional RAQA organizations to drive critical process improvement projects, resolve systemic quality issues, ensure CAPA effectiveness, and advance 3PL supply chain compliance maturity.
Essential Job Duties
· 3PL Quality Management & Worldwide Oversight
· Design, own, and continuously improve a global 3PL Quality Management Program encompassing third-party logistics providers, global distribution hubs, forward stocking locations, cold chain/temperature-controlled storage facilities, and fulfillment partners across all global regions.
· Establish and maintain qualification frameworks, quality agreements (QAs), and re-evaluation controls specific to 3PL providers and logistics vendors supporting GxP-regulated distribution processes in alignment with 21 CFR Part 820, ISO 13485 (Clause 7.5.5), EU MDR, and GDP requirements.
· Drive global harmonization of 3PL quality controls, distribution oversight, and logistics quality standards across regional entities: ISJ, ISK, IS India, IS Aubonne, ISE, ISB, and IST.
· Maintain quality oversight of 3PL operational execution, including ambient/cold-chain storage validation, environmental monitoring, product handling, serialized inventory controls, localized labeling/repackaging, and transportation controls.
· Lead Audits & Supplier / Service Qualification
· Lead and execute comprehensive risk-based audits as Lead Auditor for worldwide 3PL providers, distribution hubs, and service suppliers (sterilization, calibration, test laboratories, software/IT GxP service vendors).
· Design, own, and update 3PL audit master schedules, audit risk models, protocols, checklists, and reporting templates tailored to third-party logistics and service supplier activities.
· Conduct Lead Audits against applicable global regulatory standards including Good Distribution Practice (GDP), ISO 13485, ISO 17025, ISO 11135/11137, and 21 CFR Part 820 subpart requirements.
· Evaluate audit findings, issue formal audit reports, drive root cause analysis rigor with 3PL leadership, and manage SCAR / CAPA phase gate reviews and effectiveness verifications.
· Projects & Process Improvements
· Lead strategic quality engineering projects and continuous process improvement initiatives to optimize supply chain workflows, streamline 3PL quality oversight, and elevate supplier scorecards.
· Partner with IT and Supply Chain teams to drive continuous improvement of QMS software platforms (Trackwise, SAP, Agile) supporting 3PL quality workflows, audit scheduling, and SCAR tracking.
· Establish and analyze quality metrics, trends, and KPIs regarding 3PL performance, supplier corrective actions, and audit program effectiveness.
· Own Process Nonconformances (NCs) and CAPAs related to 3PL, logistics, and supply chain audit processes, ensuring root cause rigor (6M / 5-Why) and sustainable corrective actions.
· Supplier Controls & QMS Administration
· Manage 3PL Supplier Corrective Action Requests (SCARs) end-to-end: issuance, aging tracking, phase gate reviews, effectiveness verification, and closure.
· Support Approved Supplier List (ASL) governance regarding 3PL status maintenance, including promotions, conditional approvals, and demotions.
· Administer and maintain 3PL and service supplier records in Trackwise, SAP, and Agile, including audit files, ISO/GDP certifications, quality agreements, and ARFs.
· Regulatory Audit Support & Leadership
· Serve as SME during FDA inspections, Notified Body audits (e.g., BSI, TÜV), and internal QMS audits for all matters related to 3PL Controls, GDP compliance, Service Supplier qualification, and Supply Chain Audits.
· Operate independently to determine methods and procedures on new, complex, or special assignments with minimal supervision.
· Mentor, coach, and guide junior compliance and supplier quality engineering staff.
· May supervise or mentor the activities of junior compliance and supplier quality staff.
Required Skills and Experience
ISO 13485 Lead Auditor with demonstrated experience leading multi-site external audits worldwide.
Expert-level knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR 2017/745, and Good Distribution Practice (GDP / GMP) requirements applicable to 3PL, logistics, and service supplier controls.
Proven experience leading quality oversight and audits of global 3PLs, cold chain storage, distribution networks, and service suppliers.
Expert proficiency with QMS platforms including Trackwise, SAP, and Agile for supplier file management, SCAR tracking, and audit scheduling.
Strong understanding of risk management principles (ISO 14971) as applied to 3PL risk stratification, logistics risk assessments, and audit frequency determination.
Required Education and Training
Education: BS/BA degree in Engineering, Life Sciences, Supply Chain Management, or a related technical discipline preferred.
Experience Level: Typically requires a minimum of 12 years of related experience with a Bachelor's degree; or 8 years with a Master's degree; or a PhD with 5 years of experience; or equivalent demonstrated experience.
Industry Experience: Significant experience in a high-volume, globally distributed medical device or GxP-regulated company is required.
Working Conditions
None specified.
Preferred Skills and Experience
· Direct experience auditing and managing worldwide 3PL providers, temperature-controlled distribution, and global supply chain logistics in a regulated medical device environment.
· Exposure to auditing service suppliers and distributors in a regulated medical device environment.
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.
This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.
Accommodation & Accessibility Notice:
Intuitive is committed to providing reasonable accommodations to qualified individuals with disabilities. If you require assistance or an accommodation during any part of the application or interview process, please contact People Services at HRHelpNow@intusurg.com.
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.
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