Quality Assurance Engineer

7 days ago


Uppsala, Uppsala, Sweden Thermo Fisher Scientific Full time
Job Summary

Thermo Fisher Scientific Inc. is seeking a Quality Assurance Engineer to join our team in a world-class environment. As a Quality Assurance Manager for the group, Quality Assurance Release, you will play a key role in ensuring the release of our products, from incoming material to final product.

Key Responsibilities
  1. Verify that the activities described in the Device Master Record (DMR) are accurately carried out and make decisions about the disposition of products.
  2. Review documentation, including Device History Record (DHR), to ensure accuracy.
  3. Conduct quality assurance of deviation reports, including review and assessment of investigations and associated documentation.
  4. Approve Certificate of Analysis (CoA).
  5. Handle Legal Release Statement and Limited Release Statement on behalf of Global Regulatory.
  6. Issue, review, and approve documents within the operational area.
  7. Continuously work on constant improvements and streamlining of work processes.
Requirements
  1. Quality conscious with meticulous attention to detail and a high level of integrity.
  2. Ability to work independently, prioritize tasks, and meet lead times.
  3. Forward-thinking approach with the ability to understand the broader context and actively participate in enhancement projects.
  4. Excellent communication skills in Swedish and English, both oral and written.
  5. Equivalent skills in natural sciences, acquired through either university education or relevant work experience.
  6. Knowledge of ISO 13485 and QSR is preferred.
  7. Familiarity with the company's products and LEAN manufacturing is an advantage.
About Us

We value employment opportunities for all individuals and encourage diversity in our applicants. At Thermo Fisher Scientific, we believe that every extraordinary mind has a unique story to tell. Join us in enabling our customers to make the world healthier, cleaner, and safer.



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