Senior Quality Specialist

1 нед. назад

ИзраильSenior

quality assurancerisk managementchange controldesign controlsdocumentation managementmedical device regulation

Lead and improve quality assurance processes for AI healthcare products ensuring regulatory and industry compliance.

Aidoc is the market leader in healthcare AI and has developed the world's largest clinical frontier model, supporting nearly 50 million patients each year. Aidoc is deployed in more than 2,000 medical centers worldwide. Since our founding in 2016, Aidoc has raised over $500 million and achieved a record number of FDA-cleared solutions. Medical diagnosis is hitting a breaking point, where the number of physicians hasn't kept up with the rapidly growing patient load. This leads to misdiagnosis and treatment delays that result in hundreds of thousands of deaths every year. Aidoc assists clinicians by precisely highlighting diseases directly on medical images, preventing misdiagnosis and ensuring that urgent patients receive the immediate attention they need.

We’re seeking a Senior Quality Specialist to join Aidoc’s QA team. In this role, you’ll lead the implementation and continuous improvement of quality assurance processes — including design controls, change control, and risk management , ensuring our products meet the highest global regulatory and industry standards. Your expertise will directly impact the safety, quality, and compliance of cutting-edge AI healthcare solutions.
Lead product release processes for new medical devices and software versions, collaborating closely with R&D, Product, Delivery, and SW QA teams.
Create, Maintain and review product related documentation (DHF, DMR, DHR, TFs) with a deep understanding of product design, implementation, and testing.
Translate regulatory requirements into actionable processes , enhancing efficiency, compliance, and product quality across the organization.
Support core QMS processes including SW Development Life Cycle (SDLC), Risk Management, CAPA, Non-Conformance, Usability, Document Control, Training, and more.
Leading AI and SW quality related problem solving
Cross-functional Collaboration: Work closely with SW engineers, data scientists, and product teams to identify testing requirements, troubleshoot issues, and improve overall AI system quality.
Assist in internal and external audits , ensuring readiness and full compliance.

Be part of something big - using cutting-edge technologies to transform the Healthcare industry (while saving patients’ lives)
We work in a hybrid model, with our new offices located at 34 HaMasger Street in Tel Aviv and parking for employees.
Amazing and healthy breakfasts and lunches prepared daily by our personal chef!
Stocked up kitchen & meal card
Wellness: Aidoc employees-only gym, plus Pilates, Yoga, and functional workouts classes.
Amazing culture - collaborative, transparent & fun!
Attractive compensation package & benefits
Aidoc is deeply committed to creating an inclusive workplace, and to the principle of equal opportunity for all individuals. We prohibit discrimination and harassment based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other status protected by law.

Bachelor’s degree in Engineering, Life/Exact Sciences, Quality Assurance or Law.
3+ years in the medical device industry, proven experience in QMS processes with a 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 how they are applied in the product development lifecycle
Experience improving processes, efficiency, and workflows.
Interest or background in computer science or AI — a plus .
Exceptional project and program management skills.
Structured thinker with the ability to drive cross-functional projects to completion.
Ability to work independently with minimal supervision
Detail-oriented, proactive, and accountable.
Strong communication skills in English, both written and verbal.
Collaborative, team-oriented mindset with a passion for learning and growth.