Join our team!

We are looking for a Quality Assurance and Regulatory Affairs Engineer to join our Quality Team! 

Our Quality Assurance and Regulatory Department plays a critical role in ensuring that Quibim develops high-quality, safe, and effective software as a medical device that meets regulatory requirements and improves patients' life. Do you want to be part of it? Check the position details and apply now!

Your main tasks will be:

• Develop and maintain the company's management systems in compliance with applicable regulations and standards.
• Participate in the development and implementation of quality assurance processes for new and existing products.
• Conduct risk assessments and develop risk management plans for new products.
• Develop and maintain product documentation, including instructions for use, and technical manuals.
• Participate in internal and external audits of the company's management systems.
• Develop and deliver training on quality and regulatory topics to other employees.

You will be our ideal candidate if you have:

• Experience in Quality assurance and regulatory affairs in Healthcare companies.  
• Deep understanding of medical device regulations and standards, including FDA and ISO requirements.
• Strong background in ISO 13485 quality management system, including experience developing and maintaining QMS documentation.
  
• Experience leading internal and external audits of QMS and product documentation
• Advanced level of English 
• Integrity and proactivity.

Other skills that would be nice to have:

• Understanding of GDPR and HIPAA guidelines.
• AI knowledge

About us

We design and create pioneering tools that unlock imaging data to maximize drug programs and improve patient outcomes. By following an AI-first approach to help detect pathologies and predict outcomes in oncology/immunotherapy, rheumatology and neurology. The company is specialized in tissue profiling at every body part and imaging modality, Quibim develops novel quantitative imaging biomarkers to deeply analyze disease mechanisms, advancing in drug discovery and monitoring treatment progress. Using the power and promise of quantified imaging data and AI, Quibim makes precision medicine a reality.

Quibim is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, religion or belief, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, marital status or any other characteristic. Quibim culture ensures a fair treatment and opportunity for all.