QA Operations

ART MEDICAL is a well-funded, medical startup developing cutting-edge technologies for ICU patients. Our smART+™ platform is an intelligent, sensor-based feeding system for critical care patients that aims to prevent life-threatening in-hospital complications such as ventilator-associated pneumonia, malnutrition, and acute kidney injury. With the introduction of Nutrition Management 2.0™ to critical care patient scoring systems, the smART+™ platform monitors analyze, and prevents malnutrition and gastric aspiration in real-time. By providing optimal nutritional care and achieving up to 100% feeding efficiency, the smART+™ platform improves the standard of care and helps ICU patients recover faster.

The QA Operations, shall have a responsibility that includes:

• Provide technical support in documenting & maintaining the Quality Management System through knowledge & understanding of ISO13485 & MDR.
• Review requirements, specifications, Manufacturing Deviation (NCRs)
• Maintain updated MRB log, CAPA/SCA
• Initiate and lead periodic CAPA meeting & CAPA board log.
• Promote MRB/RCI/CAPA actions closure without undue delay
• Allocate SWR number per requirement includes all details and maintain SWR Log
• 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
• Support QA team activities per requirement.
  
  

• Degree in Biomedical / Science / Biotechnology / Engineering or equivalent
• At least 5 years of experience as a manufacturing manager in Medical Device field.
• Proven experience with manufacturing process -NCR; CAPA and MRB, maintenance, process validation and more.
• Strong interpersonal skills and ability to work in multi-disciplinary teams and influence others indirectly.
• Strong verbal and written communication skills in English.