Senior Quality Assurance Manager

4 hours ago


Stockholm, Stockholm, Sweden SallyQ AB Full time

CareDx, a leading precision medicine solutions company, is seeking a dedicated Senior QA Specialist to support their mission to build a robust quality culture and ensure product compliance. As a trusted partner in transplant care, CareDx offers innovative diagnostic solutions and services that improve outcomes for organ transplant patients.

About the Role

The Senior QA Specialist will take on a diverse QA role, coordinating a wide range of quality assurance activities and collaborating with several functions and Quality stakeholders. This position combines both strategic and hands-on responsibilities throughout all stages of the product lifecycle.

Key Responsibilities
  • Develop and maintain the Quality Management System (QMS) to ensure ongoing excellence.
  • Create and update QMS documentation in accordance with applicable regulations and industry standards.
  • Manage non-conformances, corrective and preventive actions.
  • Review and approve technical documents.
  • Responsible for overall training in quality standards.
  • Evaluate and audit distributors and suppliers.
  • Participate in product development projects as a Quality representative.
  • Support daily QA activities such as product release and change control requests.
Requirements

To succeed in this role, you should have:

  • A Master's degree in Life Sciences or related field.
  • At least 5 years of experience in RA/QA roles within medical devices.
  • Extensive understanding of Quality Management for medical devices.
  • Knowledge of ISO 13485, IVDD/IVDR, and MDSAP.
  • Strong collaboration and organizational skills.
  • Excellent communication skills in English, both spoken and written.
  • Good skills in Swedish, both spoken and written.


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