About this Quality Assurance Manager role at Thermo Fisher Scientific
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
Location/Division Specific Information:
Olink, part of Thermo Fisher Scientific, is dedicated to advancing the understanding of human disease through proteomics. Olink panels provide innovative, high-quality solutions for human protein biomarker discovery, enabling researchers to measure thousands of proteins simultaneously from just a few microliters of blood. Using highly specific and thoroughly validated assays with a wide dynamic range, Olink’s technology overcomes traditional limitations in protein analysis and supports deeper insights into human biology and disease.
Job description:
The Quality function comprises Quality Assurance (QA) and Quality Systems (QS), ensuring our products, services, and processes meet customer and regulatory requirements.
We are now looking to hire a Quality Assurance Manager to establish and maintain processes for the development, manufacture, and analysis of Olink biomarker panels. Working closely with teams across Olink, the manager will support product compliance, development projects, lifecycle management, batch release and customer service. This role is based in our Uppsala office, reporting to Head of Quality Assurance.
A Day in the Life:
- QMS Process Management: Own, maintain, and continuously improve assigned QMS processes, ensuring regulatory compliance and alignment across sites.
- Material and Product Quality: Make disposition decisions for sourced materials, components, and products in accordance with quality requirements.
- Quality Expertise and Compliance: Provide quality guidance, review and approve documentation, and deliver training to strengthen quality awareness and compliance.
- Non-Conformance and Complaint Management: Oversee investigations, root cause analysis, risk assessments, and corrective and preventive actions (CAPA).
- Product Development and Cross-Functional Collaboration: Support product development projects, ensuring quality requirements are integrated throughout the lifecycle.
- Audits and Quality Performance: Participate in internal and external audits, manage follow-up actions, and report quality metrics and trends for Management Reviews.
- Continuous Improvement and Digital Systems: Drive improvements using the PPI model, support quality systems and digital tools, and collaborate with our Umeå site (Agrisera) and Uppsala site to align QMS processes.
Technical Qualifications
- University degree in Life Science related field, for instance biotechnology, biology, or chemistry.
- Several years' experience of working with quality related tasks within Life Science.
- Strong knowledge of cGMP, ISO 13485/9001, and applicable regulatory requirements (FDA, EMA, etc.)
- Good communication skills, in writing and speech, in English and Swedish.
Soft skills
- The role requires strong analytical and communication skills to interface effectively with internal teams and external customers/regulators.
- Strong attention to detail while maintaining the broad perspective.
- Excellent interpersonal skills for cross-functional collaboration.
- Establish and maintain quality standards while supporting a culture of continuous improvement and compliance.
Why Join Us?
At Olink, Thermo Fisher Scientific, you will be part of a nurturing team that values integrity, innovation, and involvement. We offer an encouraging environment where your diverse experiences and perspectives are appreciated, enabling you to thrive and excel in your career. Come aboard and contribute significantly to global health and safety!
If you believe you’re the right fit for this role, we encourage you to submit your resume along with a cover letter highlighting your relevant experience. The last day for applications is on the 6th of December 2026.
