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Nanox AI

Quality Design

Posted 11 Days Ago
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Remote
Hiring Remotely in Israel
Mid level
Remote
Hiring Remotely in Israel
Mid level
The QA Engineer leads quality activities in R&D, ensuring compliance with regulatory standards, and oversees design controls and validation processes for medical devices.
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Nanox (NASDAQ: NNOX) is a dynamic and growing organization, focused on driving the world’s transition to preventive health care by bringing a full solution of affordable medical imaging technologies based on advanced AI and a proprietary digital source. Nanox’s vision encompasses expanding the reach of Nanox technology both within and beyond hospital settings, providing a seamless end-to-end solution from scan to diagnosis, leveraging AI for more accurate diagnostics and maintaining a clinically-driven approach.

Join Us and Make an Impact!

Being a Nanoxer means becoming part of a pioneering team that’s transforming the future of healthcare. You’ll thrive in an innovative environment, pushing the boundaries of technology and AI to drive the transition to preventive healthcare. Experience growth in a fast-paced, dynamic setting, working alongside passionate professionals who value your ideas. Our innovative environment encourages creativity and collaboration, offering you the chance to grow professionally while making a meaningful impact on global health. Shape your career and the future of medical imaging with us.

The Quality Design leads the quality activities in the R&D department, ensuring that all design and development processes comply with global regulatory standards and internal quality procedures. This role includes ownership of design controls, risk management activities, and verification and validation processes for Class II medical devices in the radiology and imaging domain. You'll serve as a Quality focal point for multidisciplinary development teams and play a key role in driving quality excellence throughout the product lifecycle.

·      B.Sc. or M.Sc. in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or related discipline.

·      3–5 years of experience in Quality Assurance within medical device R&D, preferably Class II or Class III devices

(Experience in radiology, imaging systems, or diagnostic devices – an advantage).

·      Solid understanding of ISO 13485, ISO 14971, ISO 62304, IEC 60601, and FDA 21 CFR Part 820.

·      Experience in design controls, risk management, and product Verification & Validation processes.

·      Strong documentation, analytical, and communication skills.

·      Detail-oriented, independent, and capable of working cross-functionally in a dynamic environment.

·      Effective communication and collaboration with cross-functional teams.

·      Proactive, self-driven, team player.

·      Ability to stay updated with evolving regulatory requirements and ensure continuous QMS compliance.

·      Strong interpersonal and communication skills, with the ability to influence and guide development teams.

·      Structured, organized, and able to manage multiple tasks simultaneously.

Top Skills

Fda 21 Cfr Part 820
Iec 60601
Iso 13485
Iso 14971
Iso 62304

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