Quality Engineer

Work Schedule Standard (Mon-Fri) Environmental Conditions Office At Thermo Fisher Scientific Norway, we develop and manufacture Dynabeads, a Norwegian technology used in billions of diagnostic tests worldwide, advanced cancer treatments, and life science research. Our unique bead technology enables applications that contribute directly to our Mission of making the world healthier, cleaner and safer. We are now looking for a Quality Engineer to join our team in Oslo. You will become part of an organization where quality, innovation, and continuous improvement are at the heart of what we do. How will you make an impact? As a Quality Engineer, you will help ensure that our products, processes, and quality systems meet applicable standards and regulatory requirements. You will work closely with colleagues across functions, supporting new product introductions, validation and qualification activities, risk management, investigations, and continuous improvement. Your expertise will help us maintain high-quality standards while developing and scaling technologies with meaningful real-world impact. What will you do?

• Ensure compliance with applicable quality standards and regulatory requirements
• Act as Design Compliance and Quality Lead in New Product Introduction (NPI) projects
• Lead and support risk assessments and the development of appropriate mitigation strategies
• Support validation and qualification of instruments, software, manufacturing processes, and/or analytical methods
• Investigate deviations together with cross-functional teams, perform root cause analyses, and support corrective and preventive actions (CAPA)
• Provide quality expertise and guidance across functions and projects

What will you need?

• Advanced degree with at least 3 years of relevant quality assurance or quality control experience in a regulated industry
• Educational background in Life Sciences, Engineering, Chemistry, Biology, or a related technical field
• Strong knowledge of GMP/GxP requirements and relevant ISO standards, such as ISO 9001 and ISO 13485
• Experience with quality management systems, CAPA, deviation management, and change control
• Experience with validation and/or qualification activities
• Strong knowledge of root cause analysis, investigations, and risk assessment methodologies
• Strong analytical and problem-solving skills with excellent attention to detail
• Ability to work independently and guide cross-functional teams
• Excellent communication, collaboration, and stakeholder management skills
• Experience with quality systems software and good proficiency in Microsoft Office
• Fluent communication skills in Norwegian and English, both written and spoken

Experience from the pharmaceutical, medical device, or biotechnology industry is considered an advantage. Interested? This is an opportunity to apply your quality expertise to a unique technology with applications in diagnostics, research, and advanced therapies – while working alongside colleagues who share a strong commitment to quality and innovation. Apply today and join Thermo Fisher Scientific Norway in developing and delivering technologies that help make the world healthier, cleaner and safer.