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Senior Quality Specialist
HybridFull-timeManufacturing Quality ManagementMedical DevicesHealthcare Software
Join a healthcare AI company’s quality assurance team to lead and improve processes that support the safety, quality, and compliance of medical device software.
Responsibilities
- Lead product release processes for new medical devices and software versions 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 processes
- Support QMS processes including software development lifecycle, risk management, CAPA, non-conformance, usability, document control, and training
- Lead quality problem-solving for AI and software
- Work with engineering, data science, and product teams to identify testing needs, troubleshoot issues, and improve AI system quality
- Support internal and external audits and maintain compliance readiness
Requirements
- Bachelor’s degree in engineering, life or exact sciences, quality assurance, or law
- At least 3 years of medical device industry experience, including QMS processes and a strong focus on software as a medical device
- Knowledge of FDA requirements, MDR, ISO 13485, ISO 62304, ISO 14971, and IEC 62366
- Experience with product risk assessment, requirements tracking, defect tracking, and configuration management in product development
- Experience improving processes, efficiency, and workflows
- Strong English communication skills, written and verbal
- Strong project and program management skills
Nice to have
- Interest or background in computer science or AI
Benefits
- Attractive compensation and benefits
- Daily breakfasts and lunches
- Meal card and stocked kitchen
- Employee gym and fitness classes
- Parking at the Tel Aviv office