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.
במקום לחפש לבד בין מאות מודעות – תנו ל-Jobify לנתח את קורות החיים שלכם ולהציג רק הזדמנויות שבאמת שוות את הזמן שלכם.
חינם, מהיר, מותאם אישית.
משרות נוספות מומלצות עבורך
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לחברה ביטחונית מובילה בחולון דרוש /ה מבקר /ת איכות להצטרף לחטיבת המיקרוגל RF!
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חולון
Experis Software
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למטריקס (חיפה) דרוש/ה מהנדס/ת LPI-החלפה לחל"ד
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חיפה
צפון matrix
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מהנדס/ת איכות? אנחנו מחפשים אותך!
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אשקלון
טמבור
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מהנדס.ת איכות- משרה זמנית
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ראשון לציון
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סטודנט.ית להנדסת איכות
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טבריה
אלביט מערכות
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מהנדס/ת בקרה ואבטחת איכות
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הרצליה
רמי שבירו
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