Quality Assurance Specialist

4 days ago


Solna Municipality, Sweden Cepheid Full time
Quality Assurance Engineer

Cepheid is seeking a highly motivated and detail-oriented Quality Assurance Engineer to join our Validation team in Solna. As a QA Engineer, you will play a critical role in ensuring the quality and compliance of our products and processes.

Key Responsibilities:
  • Contribute to the qualification of equipment and validation of processes
  • Represent Quality Assurance in project core teams and for tasks within manufacturing
  • 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
  • Build working relationships with cross-functional teams to ensure efficient collaboration and on-time delivery in projects
  • Work closely with Manufacturing, Regulatory Affairs, Project Management, Product Transfer, and other functions to ensure project deliverables
  • Ensure that all changes follow Cepheid's Change Management procedures
  • Support external and internal audits as required
Requirements:
  • Bachelor's degree with 3+ years of related work experience OR Master's degree with 2+ years of related work experience
  • Understanding of quality systems
  • Strong interpersonal, writing, and communication skills, fluent in English and Swedish in written and spoken
Preferred Qualifications:
  • Experience from an IVD environment and ISO13485 knowledge is a great advantage in this position

Cepheid offers a comprehensive benefits package, including health insurance, paid time off, and opportunities for career growth and development. If you are a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.



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