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.