QA/RA Manager

Join our dynamic team at DreaMed, a leading SAAS-based AI company dedicated to transforming Diabetes care through cutting-edge decision support system.

We are committed to providing millions of people with diabetes, access to expert care, revolutionizing the way healthcare is delivered.

At DreaMed, we foster a collaborative and family-like atmosphere, where innovation, challenges, and your passion for excellence converge to make a meaningful impact.

We understand the importance of work-life balance and offer a hybrid working model to support your well-being.

Join our talented team to make an impact!

The QA/RA Manager will manage the QA activities in the company and in addition, may participate in RA activities. This includes maintaining the Company’s QMS and supporting company regulatory activities. The QA/RA Manager will provide support and guidance for all company activities including clinical studies, product design and development, and post-market related activities.

Requirements:

• At least B. Sc. or equivalent in relevant areas such as, engineering, chemistry, life sciences or physics
• 5+ years experience in the medical device industry in QA roles
• Knowledge of FDA QSR, ISO 13485, IEC 62304, ISO 14971
• Knowledge and experience in writing and updating company procedures
• Experience working with an eQMS
• Extremely detail-oriented and organized
• Strong written and verbal communication and presentation skills
  
  

• Implement and enforce the company’s QMS according to the state-of-the-art regulations
• Assists in regulatory activities of the company
• Write, update, and train on company quality procedures and ensure their effective implementation across the organization
• Continuous control of existing quality procedures and their effectiveness by means of initiating and conducting Internal Quality Audits, and presenting the findings to the management
• Control of documentation and quality records
• Responsible for ECO implementation, ECO committee member and ECO approval/closure
• Coordinates analysis of quality data and trends for Quality System Management Review
• Lead quality investigations, CAPA team member
• Risk Analysis Team Member