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Aidoc is the market leader in healthcare AI, having developed the world's largest clinical frontier model supporting nearly 50 million patients annually. Deployed in over 2,000 medical centers globally, the company has raised $500M+ since 2016 and holds a record number of FDA-cleared solutions. Aidoc addresses a critical gap in medical diagnosis by using AI to highlight diseases on medical images, preventing misdiagnosis and ensuring urgent patients receive immediate attention.
You will lead the implementation and continuous improvement of quality assurance processes for medical device and software products, including design controls, change control, and risk management. Your work will ensure products meet the highest global regulatory and industry standards.
Key responsibilities include:
- Leading product release processes for new medical devices and software versions, collaborating with R&D, Product, Delivery, and SW QA teams
- Creating, maintaining, and reviewing product documentation (DHF, DMR, DHR, test files) with deep understanding of product design, implementation, and testing
- Translating regulatory requirements into actionable processes to enhance efficiency, compliance, and quality
- Supporting core QMS processes including SDLC, Risk Management, CAPA, Non-Conformance, Usability, Document Control, and Training
- Leading AI and software quality problem-solving initiatives
- Cross-functional collaboration with software engineers, data scientists, and product teams to identify testing requirements and improve AI system quality
- Assisting in internal and external audits to ensure compliance readiness
The role is hybrid, based at Aidoc's Tel Aviv office (34 HaMasger Street), with parking available.
Requirements:
- Bachelor's degree in Engineering, Life/Exact Sciences, Quality Assurance, or Law
- 3+ years in the medical device industry with proven QMS process experience, strong focus on SaMD (Software as Medical Device)
- Strong knowledge of FDA requirements, MDR regulation, ISO 13485, ISO 62304, ISO 14971, and IEC 62366
- Skilled in product risk assessment, requirements management and tracking, defect tracking, configuration management, and their application in product development lifecycle
- Experience improving processes, efficiency, and workflows
- Interest or background in computer science or AI is a plus
- Exceptional project and program management skills
- Structured thinking with ability to drive cross-functional projects to completion
- Ability to work independently with minimal supervision
- Detail-oriented, proactive, and accountable
- Strong English communication skills (written and verbal)
- Collaborative, team-oriented mindset with passion for learning and growth
