סקירה כללית
Quality Assurance Team Leader Herzliya | Hybrid Model | Medical Device (Class III) A leading medical device company is seeking a Quality Assurance Team Leader with proven experience in Class III devices (must!) to lead the Quality team and drive QMS and regulatory processes across the organization. Responsibilities
• Lead and manage the Quality Assurance team
• Maintain and oversee the QMS in compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR
• Manage CAPA, non-conformances, complaints, MRB, risk management, and training
• Provide operational support: manufacturing, validations, and supplier quality
• Lead internal and external audits, including preparation and execution
• Support regulatory submissions
• Collaborate cross-functionally with R&D, Regulatory, Operations, and Clinical teams Requirements
• Minimum 5 years of experience leading/managing QA teams in Class III medical devices – must
• B.Sc. in Engineering or Life Sciences
• Strong knowledge of FDA QSR, ISO 13485/14971, and EU MDR
• Experience leading RCA investigations, CAPA processes, and using statistical tools
• Excellent communication skills and fluency in English
• Advantage: Auditor certification, experience with ERP/eQMS systems
דרישות המשרה
• Lead and manage the Quality Assurance team
• Maintain and oversee the QMS in compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR
• Manage CAPA, non-conformances, complaints, MRB, risk management, and training
• Provide operational support: manufacturing, validations, and supplier quality
• Lead internal and external audits, including preparation and execution
• Support regulatory submissi
