QA & Regulation Specialist

PixCell Medical, a pioneer in point-of-care hematology analyzers, is seeking a dedicated Quality Assurance Specialist to join our innovative team in Yokne'am Illit, Israel.

About the Role

As a QA & regulation Specialist, you will play a crucial role in ensuring the quality and regulatory compliance of our cutting-edge in vitro diagnostic (IVD) analyzers. You'll work closely with our multidisciplinary teams to maintain and improve our Quality Management System (QMS) while supporting our global operations.

Key Responsibilities

• Maintain and continuously improve the company's QMS in accordance with internal procedures, international standards, and regulations
• Support external and internal quality audits, including supplier audits
• Prepare and maintain Technical Files for various products, submitting them to relevant regulatory bodies
• Manage documentation for different products, including DMR, DHF, TF, and DHR
• Execute ongoing quality improvement processes, including ECO processes, reviews, trainings, and effectiveness assessments
• Perform Corrective and Preventive Action (CAPA) activities
• Conduct non-conformity (NCR) investigations and root cause analyses
• Lead problem-solving initiatives using quality tools and methodologies
• Collaborate with multiple departments including production, R&D, and operations

Qualifications

• Bachelor's degree in Biomedical Engineering, Material Science, Medical Laboratory Science, or a related field
• Minimum 3 years of experience in a similar QA role within the medical device industry
• Strong understanding of QMS processes and regulatory requirements, including ISO 13485 and FDA regulations
• Experience with internal audits and quality documentation.
• Excellent project management and communication skills
• High proficiency in English, both written and spoken.

What We Offer

• Opportunity to work on innovative medical diagnostic technology with global impact.
• Collaborative and dynamic work environment in a growing company.
• Competitive salary and benefits package.

Join PixCell Medical and be at the forefront of revolutionizing point-of-care diagnostics. Help us make lab-grade blood testing accessible worldwide

To apply, please send your CV to [email protected].