Israel Job Openings
ART Medical
QA Operation Engineer - Israel
Netanya
November 3, 2024
ART MEDICAL is a well-funded, medical startup developing cutting-edge technologies for ICU patients. Our sm ART+™ 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 sm ART+™ 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 sm ART+™ 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
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.
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