דרושים QA Engineer Non-Conformity Leader בנתניה

Our smART+™ platform is a sensor-based feeding system for intensive care unit (ICU) patients. It aims to prevent life-threatening complications such as ventilator-associated pneumonia, malnutrition, and acute kidney injury. We recently introduced Nutrition Management 2.0™, which is a comprehensive, guideline-driven approach that aims to improve nutrition while reducing feeding complications. Combined with our smART+™ platform, it monitors, analyzes, and prevents malnutrition and gastric aspirations in real time. By improving nutrition and achieving 100% feeding efficiency, the smART+™ platform greatly reduces hospital-acquired complications and speeds up ICU patient recovery.

This is a temporary position (Maternity Leave Cover) for a period of 8-9 months, with an option to extend to permanent employment.

The QA Engineer Non-Conformity Leader , shall have a responsibility that includes:

• 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- analyzing 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.