QA Manager - Israel

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, analyzes 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.
We are looking for an experienced QA Manager to join our collaborative and growing team.

Role & Responsibilities

• Manage and maintain the company quality management system in accordance with ISO 13485: 2016, EU MDR 2017/745 and FDA 21 CFR Part 820 (QSR), and other relevant standards and regulations.
• Direct management of the QA team (QC, design control, QA engineers, document control)
• Preparing and implementing quality assurance policies and procedures.
• Ensures the facility process validation system is executed appropriately and maintains compliance with medical device expectations and master validation plans.
• Manage CAPA/NC/MRB investigations process and reports
• Ensures internal audit plans are developed and deployed and builds capability for lead auditors across the site to conduct internal audits.
• Ensures that processes are delivering their intended outputs by selection and review of critical quality KPIs and run-to-target methodologies.
• Handle supplier quality management, including supplier qualification and evaluation, quality agreements, and conducting supplier quality audits.
• Provide quality support and guidance to Operations and Manufacturing teams, under quality system requirements.
• Review DMR and manufacturing documents, work instructions and procedures, engineering/design change reports (ECOs) and provide inputs related to QA/QC.
• Review and approve manufacturing records (DHR) as part of the lot/batch release approval process.
• Ensures incoming materials meet raw material specifications with the authority to reject nonconforming raw materials. Communicates material issues and partners with suppliers to improve performance through the SCAR (Supplier Corrective Action Request) process as appropriate.
• Ensures the finished product shipped from the facility conforms to the Finished Product Specification (FPS) and is documented in a device history record.
• Ensures the online asset test equipment and product test laboratory equipment are calibrated and all personnel performing product testing or inspection are qualified.

Requirements

• Bachelor’s degree in related field of engineering, science, or regulatory affairs, or equivalent experience.
• Minimum 10 years’ experience in medical device industry.
• Experienced with QMS and SOP development & implementation to ISO 13485: 2016, EU MDR 2017/745 and FDA 21 CFR Part 820 (QSR).
• Excellent communication and time management Skills.
• Strong attention to detail.