QA Engineer

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 Engineer shall have a responsibility that includes:

• Supports manufacturing and operation with establishment and maintenance of testing and inspection processes.
• Identifies improvements and inputs into the quality planning process.
• Reviews, revises and approves documentation for consistency and compliance with good documentation practices, QMS and regulatory requirements.
• Supports Document Control process and engineering changes
• Manage the core QMS processes such as: Non-Conformities (NCs), Failures analysis, Corrective And Preventive Action (CAPA) and SCAR processes
• Participates in continuous quality improvement efforts through the evaluation of trends in key performance indicators, audits, and corrective/preventative actions.
  
  

• Bachelor’s degree in engineering or closely related field.
• Minimum 5 years of experience in the Medical Device industry including in depth knowledge of ISO13485 .
• Minimum 3 years' experience in process validations and Non-Conformities activities.
• Strong knowledge of the FDA and EU medical device regulations, standards and guidance document.
• Proven experience in establishing procedures for maintaining high standards of product quality and reliability.
• Decisions made with in-depth understanding and interpretation of procedures, policies and business practices to achieve results.