Quality Assurance Specialist

2 days ago


Askersund Municipality, Sweden TN Sweden Full time

TN Sweden is a dynamic company with a strong focus on innovation and quality. We are looking for a highly skilled Quality Engineer to join our team in Askersund.

About the Company

At TN Sweden, we pride ourselves on having a modern organization that encourages growth and development. Our employees work in a familiar atmosphere where cooperation and personal development are encouraged. We strive to be at the forefront of our industry and are committed to producing high-quality products that meet the needs of our customers.

The position is located in Askersund, where you will report to the Quality Manager. You will be part of an inspiring and affirmative team that works together towards set goals.

About the Role

In this role, you will ensure that products and processes meet established specifications and quality standards. You will use collected findings to identify opportunities for continuous improvement and collaborate closely with production, logistics, and project departments to ensure product quality and processes meet requirements.

You will act as a Role Model for Safety and Quality, train others, update instructions and SOPs within the QMS, and participate in the investigation of non-conformities. As you will sometimes work cross-functionally in projects, it is essential that you have both integrity and a non-prestigious approach when it comes to problem-solving and collaboration.

Key Responsibilities
  1. Perform inspections and set quality standards for in-process and finished products and materials.
  2. Train and oversee the quality team and operators in their use of control forms, procedures, and correcting quality problems.
  3. Act as Quality Change Manager.
  4. Release final and semi-final products.
  5. Ensure performance of yearly dose audits in cooperation with suppliers.
  6. Act as internal representative providing QA knowledge and strategy to complex projects.
  7. Apply quality principles, analyze quality records, prepare reports, and recommend improvements.
  8. Conduct inspections, such as verification and validation of components, materials, products, and clean rooms.
  9. Identify and address recurring problems with product quality or testing procedure reliability.
  10. Document quality issues and performance measures for management review.
  11. Lead Continuous Improvement projects, root cause analysis activities, CAPA ownership, and process/product/software validations.
  12. Perform internal audits.
  13. Support stakeholders with quality documentation upon request.
Requirements

We are looking for someone who is structured and meticulous, enjoys documentation, and is keen on learning new skills. Additionally, you should have:

  1. Proven experience working with sterilizing and clean rooms.
  2. At least 2-3 years of experience in Med-tech, pharmaceutical, or food production.
  3. Excellent English/Swedish language skills, written and spoken.
  4. Knowledge and experience working with ISO 13485 is preferred.


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