חברות הייטק בישראל ‹ Mego Afek ‹ QA Engineer

QA Engineer

Mego Afek· Medical Equipment Manufacturing

Mego Afek AC Ltd.פורסמה החודשFULL_TIME

כישורים מהמשרה

Quality EngineeringMedical Device IndustryISO13485ISO 14971Design Control

תיאור המשרה

Description The Quality Engineer will provide quality oversight for new product development, sustaining engineering changes, risk management activities, and maintenance of Design History File (DHF) documentation while ensuring compliance with applicable regulations and standards. Ensure compliance with Design Control requirements and internal procedures. Review and monitor of design planning, design reviews, design V&V, and design transfer activities for compliance. Ensure traceability between user requirements, design inputs, design outputs, risk controls, V&V activities. Review and approve ECOs, ECRs for risk, and compliance with QMS and standards. Verify that changes are properly documented, approved, implemented, and closed according to established procedures. Requirements Bachelor's degree in Engineering, Biomedical Engineering, Mechanical Engineering, Quality Engineering, or related technical/medical discipline. Certified Quality Engineer (CQE) or equivalent certification – advantage At least 5 years of Quality Engineering experience in the medical device industry. Experience with relevant standards (ISO13485, ISO 14971). Experience supporting Design Control and Change Control processes. Experience reviewing DHF, DMR, V&V protocols and reports, and other technical documentation. Fluent English (written and spoken). Proficiency in MS-OFFICE

על Mego Afek

Mego Afek: Innovators in Compression Therapy for Over 50 Years Who We Are: Mego Afek is a global leader in dynamic compression therapy, dedicated to improving patient outcomes and enhancing wellness. With over 50 years of experience, our clinically proven solutions support lymphedema, lipedema, venous insufficiency, DVT prevention, and wellness applications. Our Brands & Solutions: ✅ Lympha Press® – The most advanced and versatile lymphedema and lipedema therapy systems, backed by 20+ peer-reviewed clinical studies. ✅ Phlebo Press® DVT – Reliable, clinically proven deep vein thrombosis (DVT) prevention for hospital. ✅ Ballancer® – The industry-leading lymphatic drainage and wellness system, trusted for body contouring, cellulite reduction, and athletic recovery. What Makes Us Different? 🔹 Cutting-edge technology – Patented multi-chamber compression for optimal edema decongestion. 🔹 Clinically validated – Proven effectiveness in over 20 published studies. 🔹 Trusted by professionals – Used by physicians, therapists, hospitals, wellness clinics, and top spas worldwide. 🔹 Designed for every need – From homecare to advanced medical and wellness treatments. Global Impact: With a presence in healthcare, rehabilitation, aesthetics, and wellness, Mego Afek continues to lead the way in innovation, patient care, and quality. 📩 Connect with us to learn more about our solutions! #LymphaPress #BallancerPro #Ballancer #CompressionTherapy #Lymphedema #Lipedema #DVTPrevention #Wellness #LymphaticDrainage

לעמוד החברה

עוד משרות ב-Mego Afek

Manufacturing & NPI EngineerMego Afek AC Ltd.Manufacturing Engineer —China SiteMego Afek AC Ltd.QA Engineer – Compliance QMS (Maternity Leave Replacement)Mego Afek AC Ltd.