QA R&D Engineer at Nanox

Petah Tikva, Center District, Israel -

Full Time

Start Date

Immediate

Expiry Date

21 Mar, 26

Salary

0.0

Posted On

21 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Design Controls, Risk Management, Verification & Validation, ISO 13485, ISO 14971, ISO 62304, FDA Regulations, Documentation, Analytical Skills, Communication Skills, Detail-Oriented, Cross-Functional Collaboration, Continuous Improvement, Quality Management System, CAPA

Industry

Hospitals and Health Care

Description

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 work on breakthrough imaging technology that makes high-quality medical imaging accessible and affordable to billions of people worldwide. 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. Get hands-on with cutting-edge technology and AI, making a lasting impact on global healthcare. Our innovative environment encourages creativity and collaboration, offering you the chance to grow professionally while making a meaningful impact on global health. Together, we create extraordinary solutions. Shape your career and the future of medical imaging with us. The QA Engineer 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 QA focal point for multidisciplinary development teams and play a key role in driving quality excellence throughout the product lifecycle. Responsibilities · Lead QA activities in R&D to ensure full compliance with ISO 13485, ISO 62304, 21 CFR Part 820, and other applicable standards. · Act as the owner of design control processes, ensuring proper documentation, reviews, approvals, and adherence to regulatory requirements. · Lead and participate in risk management activities (ISO 14971), including FMEAs and cross-functional design reviews. · Review and approve design documentation, including verification and validation (V&V) protocols, test plans, and reports. · Ensure robust traceability between requirements, design outputs, risks, and V&V activities. · Lead and support CAPA, NCR, and Change Control processes related to product design and development. · Contribute to the maintenance and continuous improvement of the Quality Management System (QMS). · Assist in the preparation and successful execution of external audits and regulatory inspections. · Drive quality awareness within R&D and support internal training initiatives. · Serve as a quality Subject-Matter Expert (SME) for multidisciplinary teams, suppliers, and internal stakeholders. Requirements · 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. Skills null

Responsibilities

The QA Engineer leads quality activities in the R&D department, ensuring compliance with regulatory standards and internal procedures. This includes ownership of design controls, risk management, and verification and validation processes for medical devices.