- Published: September 19, 2021
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:
- Support the development and implementation of relevant QMS processes and procedures, quality objectives and plans.
- Provide technical support in documenting & maintaining the Quality Management System through knowledge & understanding of ISO13485 & MDR.
- Review requirements, specifications, lead Design Control and Change Control process, Manufacturing Deviation (NCRs), and relevant Document Control.
- Lead Risk Management process.
- Support process validation activities.
- solving problems related to manufacturing departments, sub-contractors, suppliers, and customers.
- Assist with the development and implementation of regulatory procedures.
- Initiate and lead continuous improvement of the Quality systems and processes.
- At least 3 years of experience as a QA Engineer in a Medical Device company, familiar with R&D and manufacturing process. Experience as Design Quality Assurance is an Advantage.
- Degree in Biomedical / Science / Biotechnology / Engineering or equivalent.
- Analytic capabilities, detail, and task-oriented.
- Strong verbal and written communication skills in English.
- Strong interpersonal skills and ability to work in multi-disciplinary teams and influence others indirectly.
- Prior experience with international companies - an advantage.