Quality Assurance Specialist

3 days ago


Stockholm, Stockholm, Sweden RaySearch Laboratories AB (publ) - Stockholm Full time

At RaySearch Laboratories AB (publ) - Stockholm, we are committed to improving cancer care through innovative software solutions. We develop and market advanced treatment planning systems for radiation therapy. Our team is responsible for ensuring the quality and regulatory compliance of our products. As a Quality Assurance Specialist, you will play a key role in maintaining our Quality Management System (QMS) and ensuring that our products meet the highest standards of quality and safety.

About the Role

This position is based at our office in Stockholm and requires previous experience from maintenance of QMS, including document management, CAPA management, and change management. The QA/RA team is central to the company's business as it is responsible not only for the QMS but also for product market clearances, vigilance, and internal and external audits.

As Quality Assurance Specialist, you will report to the Quality & Regulatory Affairs Director and be involved in all areas of the department. You will manage the project for transitioning our QMS from one digital platform to another, manage the CAPA process, assist our IT department in validating tools supporting the QMS, and assist with internal audits, external audits, and inspections.

Your Main Tasks:
  1. Manage the project for transitioning our QMS from one digital platform to another
  2. Manage the CAPA process and coach the organization regarding management of individual CAPAs
  3. Assist our IT department in validating tools supporting the QMS
  4. Assist with internal audits, external audits, and inspections

We are looking for a highly structured and meticulous professional with an interest in QMS related tasks and experience from project management. You should adapt to changing conditions, have good communication skills, and be well-organized but flexible when required. It is essential that you recognize the importance of written processes and instructions and take initiatives to fill in any missing pieces.



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