We are seeking a Quality Assurance (QA) Manager who will be responsible for establishing and maintaining a Quality Management System (QMS) that adheres to FDA, CE, and ISO 13485 guidelines and standards.
The QA Manager will ensure that quality standards are met and any deviations from protocols, standards, or guidelines are thoroughly investigated and addressed.
Additionally, the QA Manager will provide comprehensive training and ensure that the organization is prepared for inspections.
This role will have management responsibility over the QA and Quality Control (QC) teams within the company.
The QA Manager will report directly to the CEO or VP of Regulatory Affairs and Quality Assurance.

Responsibilities:

• Drive a cultural change towards QA compliance in a company that currently lacks a QMS.
• Develop and implement a strategic work plan for the QMS that aligns with FDA, CE, and ISO 13485 requirements, supporting research, product development, manufacturing, and post-marketing surveillance.
• Prepare the company for ISO 13485 certification.
• Provide leadership and mentorship to the QA and QC teams, ensuring sufficient support and resources for QMS areas.
• Lead and support internal and external audits/inspections, including those from customers, regulatory bodies, or health authorities. Maintain a constant state of readiness for inspections across all departments.
• Lead or support the investigation of non-conformances, implementing effective corrective actions and preventive action plans (CAPAs) based on best practices.
• Oversee and drive improvements in the training program, document control, and supplier quality activities to enhance effectiveness.

Position Requirements:

Education:

• Master’s or Ph.D. in Life Sciences or Engineering.

Experience and Skills Required:

• Proven experience in implementing and/or maintaining quality management systems within the diagnostic or Medical Device industry.
• Experience in transitioning from an R&D environment to a manufacturing environment and driving cultural change accordingly.
• Demonstrated ability to effectively communicate the value and importance of the QMS to colleagues at all levels, driving compliance and continuous improvement.
• Experience in managing QA and QC teams.
• Ability to lead cross-functional teams in problem-solving and execution.
• Excellent communication skills in both Hebrew and English.
• Proficiency in computer skills, including MS Office Suite and Laboratory Management Systems.