QA Engineer (Maternity Leave Cover) - Israel

ART MEDICAL is a well-funded medical startup transforming ICU care through advanced technology and innovation. Our smART+™ Platform is an intelligent, sensor-based solution that optimizes nutrition delivery while reducing the risks of ventilator-associated pneumonia and malnutrition. Supported by clinical trials, we are setting a new standard in critical care by achieving nearly 100% feeding efficiency and reducing ICU stays by an average of 3.3 days.

We are looking for an experienced QA engineer to join our team. In this role, you will lead testing activities across our applications, ensure product reliability, and support the delivery of high-quality releases.
This is a temporary position (Maternity Leave Cover) for a period of approximately 8-9 months, with an option to extend to permanent employment.

Role & Responsibilities
Provide technical support in documenting & maintaining the Quality Management System through knowledge & understanding of ISO13485 & MDR.
Alert management on critical issues and delay in tasks closure .
Continues improvements on the relevant processes.
Co-operate with RA/QA/QC team to comply with regulations.
Provide technical support in documenting & maintaining the Quality Management System through knowledge & understanding of ISO13485 & MDR.
Review requirements, specifications, and technical design documents to provide timely and meaningful feedback.
Suppliers- Control, monitor and approve all suppliers, perform and approve supplier evaluation, etc.
Customers- analysing issues reported via customer feedback, maintaining records and implementing changes to manufacturing when necessary.
Support QMS- logistic activities for compliance with the approved written procedures and requirements.
Discussing and solving problems related to manufacturing departments, sub-contractors, suppliers, and customers.
Assist with the development and implementation of regulatory procedures.
Requirements
Degree in Biomedical / Science / Biotechnology / Engineering or equivalent.
At least 4 years of experience as a QA Engineer in a Medical Device company.
Proven experience with manufacturing process – Process validation, review of work instructions, drawings, RR etc.
Analytic capabilities, detail, and task oriented.
Strong interpersonal skills and ability to work in multi-disciplinary teams and influence others indirectly.
Strong verbal and written communication skills in English.