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6 jobs similar to Staff Supplier Quality Engineer - ISO 13485 Lead Auditor - Remote from USA

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US

  • Ensures supplier compliance with ISO 13485, MDSAP, and EU MDR regulations.
  • Conducts supplier audits as Lead Auditor and owns supplier quality processes, SCARs, and CAPAs.
  • Partners with cross-functional teams to improve supplier controls and supports regulatory inspections.

Intuitive Surgical is a global leader in minimally invasive care, best known for its da Vinci surgical systems. The company values quality, compliance, and innovation, with a cross-functional and engineering-driven culture.

US

  • Lead the ISO 9001 QMS internal audit program with full ownership and autonomy.
  • Execute risk-based audits, root cause analysis, and CAPA verification across processes.
  • Ensure continuous readiness for external registrar certification and surveillance audits.

Carnegie Robotics is a quality-driven organization committed to excellence in operational, engineering, and manufacturing processes. The company values continuous improvement and regulatory compliance under ISO 9001.

US

  • Own and continuously improve the Quality Management System for simulation products, programs, and services.
  • Serve as the primary quality liaison for customers, suppliers, and subcontractors, ensuring requirements flow down and are met.
  • Drive risk-based audits, CAPA activities, and root-cause analysis to improve quality performance and compliance.

Aechelon Technology, a Shield AI company, produces 3D simulator content including geospecific visual/sensor databases and realistic 3D models for pilot training. The company seeks passionate people committed to real-time computer graphics and the mission of improving pilot safety.

UK

  • Deliver engaging and effective training courses in line with SGS Academy standards.
  • Deliver Internal Auditor and Lead Auditor training, virtually and in-house, tailored to client needs.
  • Maintain up-to-date knowledge of ISO 13485 to uphold SGS's reputation for excellence.

We are SGS, the world's leading testing, inspection and certification company, recognized as a global benchmark for quality and integrity. Our 100,000 employees operate 2,600 offices and laboratories, working to enable a better, safer world.

US

  • Lead GCP quality for clinical studies as the primary Quality point of contact from start-up through close-out.
  • Build the GCP quality framework, authoring SOPs, quality plans, and risk management aligned with ICH E6(R3).
  • Qualify and audit CROs, clinical sites, and vendors, and partner on inspection readiness.

Osanni Bio is a development-stage therapeutics platform headquartered in San Francisco, California, advancing programs in ophthalmology, cardiology, and beyond. They are a creative, agile team of innovators guided by core values of integrity, impact, agility, and collaboration.

Europe

  • Lead the global supplier quality organization to ensure materials and services meet quality, regulatory, and customer requirements.
  • Define and implement the supplier quality strategy, driving audits, corrective actions, and continuous improvement.
  • Partner with procurement, engineering, and manufacturing teams to resolve quality issues and promote a zero-defect mindset.