Quality Engineer - Analysis Service

Who we are

Olink, part of Thermo Fisher Scientific, is transforming the understanding of human diseases through advanced proteomics. We are driven by a commitment to innovation, quality, and transparency, providing exceptional solutions and support for human protein biomarker discovery.

For many years, the critical role of proteins in human biology has been recognized, but technological constraints limited comprehensive research into their potential across various biological processes and diseases. With our innovative Olink solutions, scientists can now measure thousands of human proteins simultaneously using just a few microliters of blood. Our highly specific and validated assays cover a wide dynamic range, empowering groundbreaking research.

Our services include flexible protein biomarker solutions, with a robust library of thoroughly validated assays covering ~5000 proteins. As we expand globally, we continue to play a pivotal role in shaping the future of scientific discovery. To learn more, visit www.olink.com.

Position Description

The Quality unit, a part of the Analysis Service department, is looking to hire a Quality Engineer. At Analysis Service, protein expression analyses are performed for various customers in academia and the Life Science industry to identify biomarkers. We read out the expression with qPCR or with NGS methodology.

The Quality unit is responsible for ensuring quality and that samples, analyses and data are handled in accordance with applicable laws and regulations as well as for managing our quality management system. In this role, you will support the business by maintaining quality throughout the workflow by, for example, reviewing and releasing results to customers and managing governing documentation, SOPs, etc. and being responsible for instrument documentation.

As Quality Engineer, you will also be responsible for managing deviations within the department, participating in customer audits and handling other quality-related issues from our customers. You will report to the Quality Manager at Analysis Service and be located at the head office in Uppsala.

Primary Responsibilities

1. Responsible for CAPA, CC, deviations and risk management within the department.
2. Evaluate the effectiveness of the quality management system and investigate trends.
3. Manage, organize and archive controlled documents.
4. Write, update and review SOP/instructions/reports in collaboration with others.
5. Approve data to be delivered to customers.
6. Plan, implement and document quality training for staff.
7. Be supportive in quality issues regarding equipment (qualification, maintenance and control).
8. Represent Analysis Service at internal as well as customer audits.

Qualifications

1. Bachelor's degree or equivalent in the Life Science field.
2. Experience working with quality in a contract laboratory or QC laboratory with a QMS based on ISO17025 or GCP is a strong merit.
3. Experience with LIMS and/or document management systems.
4. Good oral and written communication skills in English are a requirement, good knowledge of Swedish is an advantage.

Soft Skills

As a person, you are committed, independent and you thrive in a dynamic, fast-paced environment. You are a meticulous problem solver and have a sense of quality, and you can be pragmatic when needed. Finally, you are a team player who is good at communicating and can see things from different perspectives. We place great importance on your personal qualities.

The application deadline is 2025.05.11. The role may be filled before the application deadline.

If you have experience in ensuring quality assurance systems for production within Life Science or laboratory work, GLP/GMP/GCP/similar and thrive in a fast-paced, dynamic work environment, please do not hesitate to apply!