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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.
Requirements:
- 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
