תיאור תפקיד:
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
דרישות:
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
היקף משרה:
לפי שעות
קוד משרה:
986047
אזור:
מרכז - תל אביב, פתח תקווה, רמת גן וגבעתיים, בקעת אונו וגבעת שמואל, חולון ובת-ים, מודיעין, שוהם
שרון - רעננה, כפר סבא והוד השרון, ראש העין, הרצליה ורמת השרון
השפלה - ראשון לציון ונס- ציונה
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