Production Quality Specialist

Aidoc is recruiting a Production Quality Specialist in Tel Aviv. Join our team!

Aidoc is revolutionizing clinical decision-making with real-time clinical AI imaging solutions, impacting over 60 million patients annually. Our technology empowers physicians to diagnose urgent cases, ultimately improving patient outcomes.

Powered by our proprietary aiOS, Aidoc assists clinicians by precisely highlighting suspected pathological findings directly on medical images and prioritizing cases. This ensures that urgent patients receive the immediate attention they need.

As a leader in clinical AI, Aidoc has the most FDA-cleared Computer-Aided Detection (CAD) solutions, with adoption in more than 1,600 medical centers worldwide. 

Since our founding in 2016, Aidoc has secured over $370 million in funding and was recognized as one of TIME’s 50 most genius companies.

The Quality team at Aidoc is responsible for defining quality processes related to the development, release, and servicing of Aidoc’s products, in light of medical device and quality management standards and regulations.

The team’s role is to ensure Aidoc complies with applicable standards and regulations, while strengthening the company’s processes and products’ quality.

The Production Quality Specialist is a key role, collaborating with the Delivery and R&D departments to ensure the quality and compliance of post-production activities.

• Process Definition and Management: Define post-production processes, including configuration management, deployment, servicing, and infrastructure-related changes.
• Compliance Assurance: Ensure all processes and associated records adhere to ISO 13485 and other relevant Quality Management System (QMS) standards and regulations.
• Quality Principle Implementation: Implement critical quality management principles, such as risk management and traceability.
• Record Review: Review process outputs (records) to verify compliance with established company processes.
• Audit Support: Support and prepare the company for both internal and external audits.

• At least 3 years of experience as a QA/Support/Project Manager in a SaMD company.
• Bachelor’s degree in Life/Exact Science/Engineering/Quality Assurance or related fields.
• Exceptional process engineering skills.
• Strong knowledge of FDA requirements, MDR regulation, ISO 13485, ISO 62304, ISO 14971 and IEC 62366 - an advantage. 
• 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.

Our Perks:

• 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