Quality Assurance Manager

Responsibilities

• Responsible for managing or governing all QMS-related processes per ISO 13485 standard e.g., CAPA, Nonconformance, Changes, Complaints handling, Recalls, Data analysis, Risk management.
• 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.
• 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.
• Maintaining design control activities by ISO13485.
• Ensuring validation processes are performed and documented.
• Provide support for risk analysis processes and technical file maintenance.
• Working closely with the Medical Engineering team and R&D team
• Making the quality world accessible to the Engineering and R&D team
• Reports directly to the VP of Regulatory Affairs & QA

Qualifications

• Bachelor’s degree in Engineering or scientific discipline- required.
• 2+ years experience managing a team (with at least 3 members)
• 4-6 years of experience in quality assurance, in Medical devices.
• Excellent familiarity and previous experience with Medical devices design control process per ISO13485 and 21 CFR Part 820.30
• 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.