QA Operation Engineer- Israel

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 analyzes, 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.

As a QA Operation Engineer, you will work closely and collaboratively with our R&D, Engineering, and Production teams, playing a pivotal role in ensuring top-tier quality and innovation

Role & Responsibilities

• 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.
• Responsible for Suppliers’ quality issues.
• Participates in continuous quality improvement efforts through the evaluation of trends in key performance indicators, audits, and corrective/preventative actions.

Requirements

• Bachelor’s degree in engineering or closely related field,
• 3-5 years’ experience in a manufacturing environment and Supplier Quality in medical device industry, including in depth knowledge of ISO13485 .
• 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.