Quality Assurance Specialist

3 days ago


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

RaySearch develops innovative software solutions to improve cancer care. The company has over 40 years of experience in the field and has established itself as a leading provider of software for radiation therapy.

As a QA/RA Specialist, you will be part of a team responsible for ensuring the quality and regulatory compliance of our products. You will work closely with cross-functional teams to develop and implement quality management systems, manage CAPA processes, and assist with internal and external audits.

The role requires previous experience from maintenance of Quality Management Systems (QMS), including document management, CAPA management and change management. Knowledge of ISO 13485, MDR or QSR is also essential.

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

You will have contact with all departments at our headquarters and work closely with an international team happy to share knowledge.



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