Molecular Diagnostic Quality Assurance Professional

17 hours ago


Solna Municipality, Sweden Cepheid AB Full time

Cepheid AB is committed to improving healthcare through innovative diagnostic solutions. As a Quality Assurance Engineer, you will contribute to the development and implementation of quality assurance programs that ensure compliance with regulatory requirements.

The ideal candidate will have a strong understanding of quality systems, including ISO13485, and experience working in an IVD environment. You will be responsible for representing Quality in project core teams and ensuring that all project deliverables/documents are executed and documented in compliance with Cepheid's QMS and applicable regulatory requirements.

Responsibilities
  • Represent Quality in project core teams and for tasks within manufacturing such as IQOQs and process changes.
  • Ensure that all project deliverables/documents are executed and documented in compliance with Cepheid's QMS and applicable regulatory requirements.
  • Facilitate and/or assure Risk Management activities (FMEAs) throughout the entire Life Cycle.

Cepheid AB offers a comprehensive array of benefits that add value to our lives. Whether it's a healthcare program or paid time off, our programs contribute to life beyond the job.



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