Job requirements and application form

This role is responsible for ensuring compliance, quality, and operational excellence throughout the development and manufacturing of Class III medical devices. Responsibilities • Ensure compliance with FDA regulations, ISO 13485/14971, EU MDR, and applicable standards. • Lead and manage CAPA, complaints handling, standards gap analysis, internal audits, and management reviews. • Oversee and support MRB activities, change control, process controls, validations (PV, EQ), pFMEA, risk management, and statistical process monitoring. • Prepare for and support external and internal audits (FDA, ISO, Notified Bodies). • Collaborate with cross-functional teams and train staff on QA best practices. Location: Sharon district, Israel (Hybrid)

• Bachelor’s degree in Engineering, Science, or a related field. • 5+ years of QA experience in Class III medical device environments. • In-depth knowledge of FDA 21 CFR Part 820, ISO 13485/14971, and EU MDR. • Experience conducting investigations, identifying root causes, leading corrective actions, and applying risk management and statistical tools. • Strong written and verbal communication skills, with excellent analytical and problem-solving abilities. • Auditor certification and experience with ERP/eQMS systems are an advantage.