Quality Assurance Manager

Quality Manager Position

The Quality Assurance (QA) Manager will report directly to the CEO, overseeing all aspects related to the quality system and collaborating closely with the production, engineering, R&D (Engineering and Bio), Purchasing, and Marketing teams.

Job Description:

• Leadership of the Quality Management System (QMS):
• Draft, review, and approve company documents, specifications, drawings, and procedures.
• Lead the implementation of quality processes and improvement mechanisms, including document control, change control, deviation handling, and preventive/corrective actions (ECO, NCR, MRB, CAPA).
• Engagement with International Authorities:
• Work with international bodies such as Notified Bodies and regulatory consultants.
• Lead, inspect, and coordinate external audits for CE, ISO 13485.
• Ensure traceability through meticulous document tracking.
• Management Responsibilities:
• Prepare and present management reviews.
• Address and resolve customer and supplier complaints.
• Manage the company's training and certification activities.
• Monitor and manage technical files.
• Follow up on testing and obtain approval for technical tests.
• Oversee the sterilization process.
• Schedule internal audits and conduct supplier audits and evaluations.
• Monitor and control subcontractors.

Job Requirements:

• Academic degree in life science, medicine, pharmacy, engineering, or a related discipline.
• Certification or other evidence of formal qualification in quality management.
• Knowledge in the field of medical devices with a minimum of eight (8) years of professional experience in QMS (ISO 13485) and regulatory affairs of medical devices, including at least three (3) years in a management role.
• Proven experience with CE, FDA, and EMEA regulatory compliance.
• Experience with both Hardware, Software, and single-use components.
• Advantageous background in managing the transfer from R&D to production and mature products.
• Excellent reading, writing, and communication skills in English and Hebrew.
• Strong reporting, teamwork, and time management skills.
• Ability to learn quickly, analyze problems, work independently, and effectively organize and execute multiple work tasks