Staff Supplier Quality Engineer – ISO 13485 Lead Auditor

🔥 5 minutes ago

🍑 Georgia – Remote

🍑 Georgia – Remote

💵 $155.5k - $263.1k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

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 and maintain 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 • Maintain quality oversight of 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 • Create and maintain 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 • Partner with IT and Supply Chain teams to improve Trackwise, SAP, and Agile workflows • 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 3PL and service-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 independently • Mentor, coach, and guide junior compliance and supplier quality engineering staff

🎯 Requirements

• ISO 13485 Lead Auditor experience 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 • Proven experience overseeing and auditing 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 related technical discipline preferred • Minimum 12 years of related experience with a Bachelor's degree; or 8 years with a Master's degree; or PhD with 5 years of experience; or equivalent demonstrated experience • Significant experience in a high-volume, globally distributed medical device or GxP-regulated company • Willingness to travel 50% internationally • Current proof of vaccination against certain diseases, including COVID-19, may be required • Candidates may be subject to U.S. export-control licensing or a Technology Control Plan • Qualified applicants must meet applicable U.S. work authorization/export-control requirements where applicable

🏖️ Benefits

• Remote work arrangement; employees come onsite when requested by the leader • Incentives • Benefits • Equity • Potential vaccination coverage requirement/support depending on role • Reasonable accommodations during the application or interview process

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume