לוח משרות דרושים ביוטכנולוגיה

Our smART+™ platform is a sensor-based feeding system for intensive care unit (ICU) patients. It aims to prevent life-threatening complications such as ventilator-associated pneumonia, malnutrition, and acute kidney injury. We recently introduced Nutrition Management 2.0™, which is a comprehensive, guideline-driven approach that aims to improve nutrition while reducing feeding complications. Combined with our smART+™ platform, it monitors, analyzes, and prevents malnutrition and gastric aspirations in real time. By improving nutrition and achieving 100% feeding efficiency, the smART+™ platform greatly reduces hospital-acquired complications and speeds up ICU patient recovery. This is a temporary position (Maternity Leave Cover) for a period of approximately 8-9 months, with an option to extend to permanent employment. The QA Engineer Non-Conformity Leader shall have a responsibility that includes:
* Provide technical support in documenting & maintaining the Quality Management System through knowledge & understanding of ISO13485 & MDR.
* Alert management on critical issues and delay in tasks closure .
* continues improvements on the relevant processes.
* Co-operate with RA/QA/QC team to comply with regulations.
* Provide technical support in documenting & maintaining the Quality Management System through knowledge & understanding of ISO13485 & MDR.
* Review requirements, specifications and technical design documents to provide timely and meaningful feedback.
* Suppliers- Control, monitor and approve all suppliers, perform and approve supplier evaluation, etc.
* Customers- analyzing issues reported via customer feedback, maintaining records and implementing changes to manufacturing when necessary.
* Support QMS- logistic activities for compliance with the approved written procedures and requirements.
* Discussing and solving problems related to manufacturing departments, sub-contractors, suppliers and customers.
* Assist with the development and implementation of regulatory procedures.

Assist in maintaining the Quality Management system (QMS) to ensure compliance with ISO 13485 and 21 CFR Part 820.
Lead quality control activities, including incoming inspections, documentation writing and reviews, and final product release.
Monitor and track nonconformities, customer complaints, and corrective and preventive actions (CAPA).
Participate in internal audits, ensuring corrective actions are followed up and documented properly.
Collaborate with engineering and manufacturing teams to ensure quality requirements are met throughout the development process.
Assist in writing and maintaining regulatory documentation and records to support compliance efforts.
Support supplier Quality Assurance activities by helping review and track supplier performance.
Contribute to continuous improvement initiatives by identifying areas for enhancement in quality processes.