לצערנו המשרה כבר לא בתוקף
Support the manufacturing of medical devices in conformance with the Quality System Regulation (QSR), ISO 13485, Active Implant Medical Device Directive (AIMD), Medical Device Regulation (MDR), ISO 14971, IEC 60601, IEC 62304 and other regulatory standards
production and process control activities, release of incoming materials
and in-process inspections, release of final goods and documentation (DHR), Implementing and monitoring compliance for in-house product design and vendor management, Implement Supplier
quality processes and inspections. All under ISO 13485 and GMP compliance.
Manage documentation processes for in-house product design control
and development, process V&V, reviewer of V&V reports
throughout product development. Defining quality requirements to all products electrical
components/circuits, mechanical, etc. Provide Technical and statistical reliability support to Product Manufacturing and Quality.
Additional Routine QA activities: Non-conformances investigation, MRBs and related activities, CAPA,
Engineering change order (ECOs) and document change processes, risk management participant, update, review and approval of documentation, employee training, supporting internal and external audits. Support the QA Manager in all needed projects and activities
• Academic Degree
• Knowledge in production processes and applicable standards 7 years
• 4 years related experience in Medical Device
• 9 years experience in Quality
• Excellent English
• ASQ/CQE certification - Advantage
• IPC and J-STD knowledge & qualification
• Software Development Life Cycle and Quality knowledge – Advantage
• Hands on experience with the following standards: Electrical Safety (IEC 60601), Software (IEC 62304).