Senior Quality Specialist

About the role

Join Aidoc’s QA team as a Senior Quality Specialist, leading the implementation and continuous improvement of quality assurance processes for AI‑driven medical devices and software.

Key responsibilities

• Lead product release processes for new medical devices and software versions, working closely with R&D, Product, Delivery and SW QA teams.
• Create, maintain and review product documentation (DHF, DMR, DHR, TFs) with deep understanding of design, implementation and testing.
• Translate regulatory requirements into actionable processes to boost efficiency, compliance and product quality.
• Support core QMS processes including SDLC, risk management, CAPA, non‑conformance, usability, document control and training.
• Lead AI and software quality problem‑solving and collaborate with engineers, data scientists and product teams.
• Assist in internal and external audits, ensuring readiness and full compliance.

Required profile

• Bachelor’s degree in Engineering, Life/Exact Sciences, Quality Assurance or Law.
• 3+ years experience in the medical device industry with a focus on SaMD.
• Strong knowledge of FDA, MDR, ISO 13485, ISO 62304, ISO 14971 and IEC 62366 requirements.
• Proven ability to improve processes, efficiency and workflows.
• Excellent English communication skills, both written and verbal.

Required skills

• Product risk assessment and management.
• Requirements management and tracking.
• Defect tracking and configuration management.
• Quality Management System (QMS) processes for medical software.

What we offer

• Hybrid work model with modern offices in Tel Aviv.
• Daily healthy breakfasts and lunches prepared by a personal chef.
• Stocked kitchen, meal card and employee‑only gym with fitness classes.
• Collaborative, transparent and fun company culture.
• Attractive compensation package and benefits.