Senior/Quality Assurance Engineer

5 days ago

Herzliya, Tel Aviv, Israel Endospan Ltd. Full time $70,000 - $120,000 per year

Company Description

Endospan Ltd., headquartered in Herzliya, Israel, is a pioneer in the endovascular repair of aortic arch disease, including aneurysms and dissections. The company's NEXUS Aortic Arch Stent Graft System is the first CE-approved, off-the-shelf branched endovascular system addressing a wide range of aortic pathologies. The innovative NEXUS "Dock and Lock" modular system ensures stable anatomical anchoring and atraumatic sealing in various anatomies, providing a minimally invasive alternative to open-chest surgery for patients with aortic arch disease.

Senior/QA Operations Engineer – Medical Devices (Herzliya, Hybrid)

We are looking for a Senior/QA Operations Engineer to join our team in Herzliya (hybrid work available). This role ensures compliance, quality, and operational excellence in the development and manufacturing of Class III medical devices.

Responsibilities

  • Ensure compliance with FDA, ISO 13485/14971, EU MDR, and related standards.
  • Oversee supplier/subcontractor quality, MRB, change control, and controlled documentation.
  • Lead process controls, validations (PV, EQ), pFMEA, risk management, and statistical process monitoring.
  • Support design controls, cleanroom monitoring (ISO Class 7), and sterilization processes.
  • Prepare for and support audits (FDA, ISO, notified bodies).
  • Collaborate with cross-functional teams and train staff on QA best practices.

Qualifications/requirements

  • Bachelor's degree in Engineering/Science or related field.
  • 3+ years in Class III medical devices with strong QA operations experience.
  • Deep knowledge of FDA 21 CFR Part 820, ISO 13485/14971, EU MDR.
  • Skilled in supplier management, process validation, risk management, and statistics.
  • Strong written and verbal communication, analytical, and problem-solving skills.
  • Auditor certification, ERP/eQMS experience are a plus.

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