Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Engineer I, QA

Thermo Fisher Scientific Inc. is seeking an Engineer I, QA to join our world-class team in Uppsala, Sweden. 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. This is a unique opportunity to contribute to the improvement and streamlining of our work processes, making a real difference in people's everyday lives.

Job Responsibilities:

• Verify that the activities described in the Device Master Record (DMR) are accurately carried out and make decisions about the disposition of products.
• Review documentation, including Device History Record (DHR), to ensure accuracy.
• Conduct quality assurance of deviation reports, including review and assessment of investigations and associated documentation.
• Approve Certificate of Analysis (CoA).
• Handle Legal Release Statement and Limited Release Statement on behalf of Global Regulatory.
• Issue, review, and approve documents within the operational area.
• Continuously work on constant improvements and streamlining of work processes.

• Quality conscious with meticulous attention to detail and a high level of integrity.
• Ability to work independently, prioritize tasks, and meet lead times.
• Forward-thinking approach with the ability to understand the broader context and actively participate in enhancement projects.
• Excellent communication skills in Swedish and English, both oral and written.
• Equivalent skills in natural sciences, acquired through either university education or relevant work experience.
• Knowledge of ISO 13485 and QSR is preferred.
• Familiarity with the company's products and LEAN manufacturing is an advantage.