QA Advisor | Medical Devices | SaMD | AI-Powered Healthcare

QA Advisor | Medical Devices | SaMD | AI-Powered Healthcare

An innovative healthcare technology company is looking for an experienced QA Advisor to lead and shape its Quality Management System (QMS) while supporting the development of cutting-edge AI-powered medical software solutions.

This is a unique opportunity to play a key role in building a quality-driven organization and preparing products for regulatory approval and commercialization.

What You'll Do?

✔ Establish and maintain a robust QMS in compliance with ISO 13485 and FDA requirements

✔ Support software development lifecycle processes according to IEC 62304

✔ Lead risk management activities in line with ISO 14971

✔ Implement and oversee Design Controls, CAPA, Change Management, Document Control, and Nonconformance processes

✔ Ensure traceability across requirements, risks, verification, and validation activities

✔ Lead internal audits and support external audits and regulatory inspections

✔ Collaborate closely with Engineering, Product, and Regulatory teams to embed quality throughout the development lifecycle

✔ Support FDA and regulatory submissions through compliant documentation and quality processes

What We're Looking For?

🔹 5+ years of Quality Assurance experience in the Medical Device industry

🔹 Hands-on experience establishing and maintaining QMS for Software Medical Devices (SaMD)

🔹 Strong knowledge of ISO 13485, FDA 21 CFR Part 820/QMSR, ISO 14971, IEC 62304, ISO 27001, and HIPAA

🔹 Experience supporting FDA and/or CE submissions

🔹 Experience in Digital Health, AI-based Medical Devices, or SaMD is highly preferred

🔹 Excellent communication and stakeholder management skills

Why Join?

✨ Opportunity to influence quality strategy from an early stage

✨ Work on innovative AI-driven healthcare technologies

✨ High-impact role with direct visibility across the organization

✨ Flexible part-time engagement with hybrid/remote work options

📍 Israel ,Part-Time Consulting Role