מהנדס/ת איכות מכשור רפואי - אזור חיפה (#1236)
תיאור
A Medical Device company in Haifa is recruiting a Quality Assurance Engineer.
Position Overview:
Oversee and analyze market feedback, ensuring timely resolutions and process improvements
conduct regular inspections on production lines, address deviations, and initiate investigations to improve product quality and prevent discrepancies.
Lead and manage CAPA and non-conformance processes, including root cause analysis, implementation of corrective and preventive actions, and verification of effectiveness.
Oversee supplier certification processes and manage SCAR, while leading and addressing non-conformities related to incoming inspections.
Lead and control production failures through MRB processes, complaints handling, and CAPA activities.
Document, implement, monitor, and maintain quality assurance activities to ensure compliance with ISO 13485, MDR, and FDA regulations.
Provide daily QA support to all departments, fostering a quality culture.
Job Scope: Full-time
דרישות התפקיד
B.Sc. degree or higher in Industrial Engineering & Management / Mechanical Engineering / Quality Engineering / Relevant education – Mandatory.
At least 2 years of experience in quality systems in the medical device industry – Mandatory.
Experience with Microsoft Office and CRM platforms
Excellent reading, writing, and communication skills in English and Hebrew.
Strong reporting, teamwork, and time management abilities
Quick learner with the ability to analyze problems, work independently, and manage multiple tasks effectively.
Highly motivated and accountable.
כישורים נדרשים
