Quality Assurance Compliance Specialist

Aidoc is recruiting an Quality Assurance Compliance Specialist in Tel Aviv. Join our team

About Aidoc:

Aidoc is a pioneering force in clinical AI. Our clinical AI imaging solutions help physicians quickly identify and diagnose urgent cases and improve patient outcomes.

Our solutions are being used daily in more than 1,000 hospitals, including leading health systems in the US. Funded by some of the industry's leading VCs, Aidoc has raised more than $250 million to date and was chosen as one of TIME's 50 most genius companies.

Our people are by far our most important asset. We see it as the most important aspect of our job to make sure our team members feel we truly care for them as humans, feel highly appreciated for their accomplishments and efforts and constantly develop their careers.

Aidoc's cultural values
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About this role:

We're seeking a
Quality Assurance Compliance 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.

Responsibilities:

• 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.

Requirements:

• 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.

Skills & Qualities

• 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.

Working at Aidoc:

Our perks:

• Be part of something big - using cutting-edge technologies to transform the Healthcare industry (while saving patients' lives)
• Incredible culture - collaborative, transparent & fun
• Office close to HaShalom train station with free parking
• Stocked up kitchen & meal card.
• Breakfast and lunch are made by our chef
• Wellness - yoga, pilates, and functional workouts in the office.
• Attractive compensation package & benefits