QA Manager

QA |

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.

Job Description:

  • 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

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