Quality Assurance Specialist

About the role

Eitan Medical, an international developer of infusion pumps and related accessories, is seeking a Quality Assurance Specialist to lead supplier quality activities and CAPA management. You will work closely with internal teams and external partners to ensure compliance with regulatory standards and internal quality objectives.

Key responsibilities

• Approve and disapprove suppliers, maintain the Approved Supplier List, and manage supplier audits (initial and surveillance) on‑site or remotely.
• Lead the SCAR process, including initiation, investigation, root‑cause analysis, and closure.
• Coordinate supplier score‑card tracking, trend analysis, and non‑conformance follow‑up.
• Serve as CAPA Coordinator, creating and overseeing CAPA plans, risk assessments, containment, correction, and verification.
• Generate quality metrics and trending data for periodic reviews and management meetings.
• Write, update, release, and sign quality documentation within the Quality Management System.

Required profile

• Practical Engineer or B.Sc. in Quality, Biomedical, Biotechnology or related field; CQM or CQE certification is a plus.
• 3–5 years of relevant experience in quality assurance, preferably in medical devices.
• Strong knowledge of ISO 9001, ISO 13485 and other international standards.
• Fluent in English and Hebrew.
• Excellent analytical, organizational and problem‑solving abilities.

Required skills

• ISO 9001, ISO 13485 compliance
• SCAR and CAPA processes
• Supplier audit execution and follow‑up
• MS Office suite (Excel, Word, PowerPoint)
• E‑Document management systems
• Statistical tools such as Excel and Minitab

What we offer

• Opportunity to work in an innovative international medical‑device environment.
• Collaborative team culture with professional development support.