9 дней назад
Senior Quality Specialist (AI)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Quality Specialist (AI/Medical Devices): Leading quality assurance processes for AI-powered medical devices and software with an accent on design controls, change control, risk management, and regulatory compliance. Focus on managing product releases, maintaining technical documentation, improving QMS workflows, and solving complex quality issues across software, data science, and product teams.
Location: Hybrid role based in Tel Aviv-Yafo, Israel; office located at 34 HaMasger Street, Tel Aviv.
Company
develops AI-powered healthcare solutions that analyze medical images and support clinicians in diagnosing urgent conditions.
What you will do
- Lead product release processes for new medical devices and software versions in collaboration with R&D, Product, Delivery, and Software QA teams.
- Create, maintain, and review product documentation, including DHF, DMR, DHR, and technical files.
- Translate regulatory requirements into practical quality processes and improve organizational efficiency and compliance.
- Support QMS processes covering software development, risk management, CAPA, non-conformance, usability, document control, and training.
- Lead problem-solving initiatives related to AI and software quality.
- Collaborate with software engineers, data scientists, and product teams on testing requirements, issue resolution, audits, and AI system quality.
Requirements
- Bachelor’s degree in engineering, life or exact sciences, quality assurance, or law.
- At least 3 years of experience in the medical device industry, including QMS work focused on software as a medical device.
- Strong knowledge of FDA requirements, MDR, ISO 13485, ISO 62304, ISO 14971, and IEC 62366.
- Experience with product risk assessment, requirements management, defect tracking, configuration management, and product development lifecycles.
- Project and program management skills with the ability to lead cross-functional initiatives independently.
- Strong written and verbal English communication skills are required.
Nice to have
- Background or interest in computer science or AI.
- Experience improving processes, efficiency, and workflows.
Culture & Benefits
- Hybrid work model with offices in Tel Aviv and employee parking.
- Daily breakfasts and lunches prepared by an in-house chef.
- Stocked kitchen and meal card.
- Employee gym and Pilates, yoga, and functional workout classes.
- Collaborative, transparent, and inclusive work environment.
- Compensation package and benefits.
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