Beyeonics Vision is a medical technology company located in Haifa, Israel. Beyeonics Vision develops Beyeonics One, a cutting-edge digital microscope for ophthalmic surgeries, integrating advanced AR/VR technologies, infrared (IR) illumination, and high-resolution imaging.
We are currently seeking a Manufacturing Engineer to join our innovative team.
Job Responsibilities:
- Ensure compliance of all departments with the Quality Management System (QMS) regulatory requirements, including ISO 13485, FDA regulations, and other applicable standards.
- Oversee design control and design transfer processes, ensuring a seamless transition of new/modified products from development to manufacturing.
- Act as the process owner for documentation control, managing the creation, review, revision, and archiving of quality documents, including SOPs, work instructions, forms, and records. Ensure document control processes align with regulatory and company standards.
- Lead the Corrective and Preventive Action (CAPA) process, coordinating investigations, root cause analyses, and implementation of corrective actions for issues identified through complaints, non-conforming materials, and audit results. Lead and support CAPA activities throughout all stages, from investigation to implementation and closure
- Represent Quality Assurance in Change Control Board (CCB) meetings, reviewing and approving Engineering Change Orders (ECOs) to ensure compliance with quality and regulatory requirements.
- Oversee the documentation and maintenance of Device History Records (DHRs) and Design Master Records (DMRs), ensuring accuracy and regulatory compliance.
- Collect and analyze quality data to identify trends, predict issues, and propose quality improvement initiatives.
- Manage equipment calibration and maintenance programs, ensuring all monitoring and measurement equipment is compliant with applicable standards.
- Train employees on quality management system processes, regulatory compliance requirements, and the importance of maintaining quality standards.
- Support operational departments, including warehouse, supply chain, production, by ensuring quality controls and compliance in their activities.
- Lead the Material Review Board (MRB) process for non-conforming materials, managing segregation, investigation, corrective actions, and final disposition.
- Manage supplier quality processes, including supplier evaluation, selection, monitoring, and conducting periodic audits. Initiate and track Supplier Corrective Action Requests (SCARs) and maintain the Approved Supplier List (ASL). Plan, execute, and manage supplier audits, ensuring compliance and driving improvement actions based on findings.
- Facilitate the complaint handling process, including receiving, evaluating, and investigating complaints, conducting root cause analysis, maintaining records, and analyzing trends for improvement opportunities.
- Collaborate with R&D and Operations teams on failure investigations, providing quality input to ensure effective root cause analysis and resolution.
- Analyze quality data, generate reports, and provide actionable insights to enhance operational processes and product quality.
- Support continuous improvement projects, contributing to the enhancement of product quality, operational efficiency, and regulatory compliance.
- Ensure readiness for internal and external audits, inspections, and certifications, supporting regulatory submissions and approvals.
Requirements:
- Engineering and/or Science Bachelor’s degree, Bio-Medical/ Biotechnology/Science degree. Preference to Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Certified Internal Auditor (CIA)
- Minimum 3 years of experience in Quality in a regulated industry (Medical Device is mandatory).
- Experience working with Regulatory Bodies and audit preparation.
- Experience with ISO 13485, 21 CFR 820, MDR, and Quality Systems Regulation is mandatory.
- Ability to work in a multi-task environment
