Staff Supplier Quality Engineer – ISO 13485 Lead Auditor

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🏈 Alabama, Florida, +9 more states – Remote

🏈 Alabama – Remote 🐊 Florida – Remote 🌾 Iowa – Remote ⚜️ Louisiana – Remote 🌪️ Oklahoma – Remote 🦀 Maryland – Remote 🎸 Mississippi – Remote 🏰 Missouri – Remote 🔔 Pennsylvania – Remote 🌴 South Carolina – Remote 🎸 Tennessee – Remote

💵 $155.5k - $263.1k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Intuitive

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1995

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Intuitive is a company known for its innovative surgical technologies, including the da Vinci Surgical Systems which are used for minimally invasive procedures. With three decades of demonstrated performance, Intuitive focuses on advancing healthcare by providing structured and measurable technology training pathways for surgeons, physicians, and OR care teams. Their vision is to improve patient outcomes through less invasive surgical care. Intuitive also offers a visual media platform for collaboration and learning, known as the Da Vinci Hub, and the Simnow platform for surgical training. The company is involved in ongoing innovation to explore new possibilities in surgical care.

📋 Description

• Design, own, and continuously improve a global 3PL Quality Management Program • Establish qualification frameworks, quality agreements, and re-evaluation controls for 3PL and logistics vendors • Harmonize 3PL quality controls, distribution oversight, and logistics quality standards across global regional entities • Oversee 3PL operational execution, including storage validation, environmental monitoring, product handling, serialized inventory, labeling/repackaging, and transportation controls • Lead risk-based audits of worldwide 3PL providers, distribution hubs, and service suppliers • Develop audit schedules, risk models, protocols, checklists, and reporting templates • Conduct audits against GDP, ISO 13485, ISO 17025, ISO 11135/11137, and 21 CFR Part 820 requirements • Evaluate findings, issue audit reports, drive root-cause analysis, and manage SCAR/CAPA reviews and effectiveness verification • Lead strategic quality engineering and continuous process improvement projects • Improve QMS platforms including Trackwise, SAP, and Agile • Establish and analyze quality metrics, trends, and KPIs • Own process nonconformances and CAPAs related to 3PL, logistics, and supply-chain audits • Manage 3PL SCARs from issuance through closure • Support Approved Supplier List governance • Maintain supplier records, audit files, certifications, quality agreements, and ARFs • Serve as subject matter expert during FDA inspections, Notified Body audits, and internal QMS audits • Determine methods and procedures for complex assignments with minimal supervision • Mentor, coach, and guide junior compliance and supplier quality engineering staff

🎯 Requirements

• ISO 13485 Lead Auditor certification/qualification 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 • Experience leading quality oversight and audits of global 3PLs, cold-chain storage, distribution networks, and service suppliers • Expert proficiency with Trackwise, SAP, and Agile • Strong understanding of ISO 14971 risk management principles • BS/BA degree in Engineering, Life Sciences, Supply Chain Management, or a related technical discipline preferred • Minimum 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 • Significant experience in a high-volume, globally distributed medical device or GxP-regulated company required • Direct experience auditing and managing worldwide 3PL providers, temperature-controlled distribution, and global supply chain logistics in a regulated medical device environment preferred • Exposure to auditing service suppliers and distributors in a regulated medical device environment preferred • Candidates may be subject to U.S. export-control requirements • Preference given to qualified applicants 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

🏖️ Benefits

• Remote work; employees come onsite when requested by the leader • Base pay, incentives, benefits, and equity • Potential vaccination coverage requirement for certain diseases, including COVID-19 • Reasonable accommodations during the application or interview process • Equal employment opportunity and anti-discrimination protections

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