Quality Assurance Manager

Beyeonics Surgical is a medical device start-up company located in Haifa, Israel. Beyeonics develops a surgical platform for spine and brain surgeries incorporating AR/VR headset, Navigation, and imaging. Beyeonics R&D group is built from a multidisciplinary collection of experts in the fields of electro-optics, mechanical, SW, HW, and algorithm engineering. Beyeonics is looking for a QA manager to join our QA & RA Department.

• Ensures the activities of all departments remain in compliance with Quality Management System regulatory requirements including managing Management reviews.
• Managing global compliance audits
• Oversee the Design Control, Design transfers, process improvements, and general operations.
• Process owner for document control activities
• Responsible for internal and supplier auditing.
• Lead the Corrective and Preventive Action process and participate in Corrective and Preventive Action (CAPA) teams in response to concerns identified through complaints, non-conforming materials, and other relevant processes.
• Represent Quality Assurance in the Change Control Board (CCB) meetings to review and disposition Engineering Change Orders (ECOs).
• Support the documentation process for Device History Records. Proposing, drafting, reviewing, and approving new or revised SOPs, work instructions, and related forms which may impact the Quality Management System.
• Collecting and analyzing statistical data to predict trends that will affect the improvement of product quality
• Oversees monitoring and measurement equipment programs
• Training employees for their impact on the quality management system.
  

• Engineering Bachelor's Degree, Bio-Medical Engineer is preferred, or an equivalent number of years of experience.
• Minimum 6 years of experience in Quality in a regulated industry (Medical Device is mandatory).
• Experience working with Notified Bodies and audit preparation.
• Experience with ISO 13485, 21 CFR 820, MDR, and Quality Systems Regulation is mandatory.
• Ability to prioritize, and work in a multi-task environment