Quality Assurance Manager- Medical Device

• Responsible for managing or governing all QMS related processes per ISO 13485 standard e.g., CAPA, Nonconformance, Management Reviews, Changes, Complaints handling, Recalls, Data analysis, Risk management.
• Provide professional QA and Regulatory guidance throughout the entire product lifecycle: from the early feasibility through planning, and development until the post-marketing stages.
• Guidance by the Design and Development requirements per ISO13485 and Product Realization.
• Assuring production line compliance and working closely with the QA at the contracted manufacturer.
• Ensuring compliance with in-house procedures through ongoing, periodic audits or inspections.
• Maintaining design control activities by ISO13485.
• Ensuring validation processes are performed and documented.
• Provide support for risk analysis processes and participation in risk management meetings.
• Working closely with the Engineering team (NPI, Validations) and with the R&D team
• Reports directly to the VP of Regulatory Affairs & QA

Position Requirements:

• A bachelor’s degree in engineering or a scientific discipline is required.
• 2+ years experience managing a team (with at least three members)
• 4-6 years of experience in quality assurance and medical devices.
• Active participation and lead at Regulatory Audits (ISO13485, MDR).
• Excellent familiarity and previous experience with Medical devices design control process per ISO13485 and 21 CFR Part 820.30
• Previous experience with FDA 21 CFR Part 820 Quality System Regulation.
• Experience with internal auditing-Advantage.
• Familiar with standards and methodologies (e.g., ISO13485, ISO14971, IEC62304)- Advantage.
• Possess excellent writing skills in English.
• Exhibit exceptional teamwork abilities and effective communication skills in both Hebrew and English