Quality Engineer

ThermoFisher Scientific; Oslo fylke; On-site; NOK 750,000 - 950,000; Full time

Job summary

Thermo Fisher Scientific Norway is seeking a Quality Engineer in Oslo. You will help ensure products, processes, and quality systems meet applicable standards and regulatory requirements, supporting new product introductions and continuous improvement.

You will lead risk assessments, validation activities, investigate deviations with cross-functional teams, and provide guidance across projects. The role requires an advanced degree and at least 3 years QA experience in regulated industries, with

Qualifications

• Advanced degree and minimum 3 years in QA in a regulated industry.
• Background in Life Sciences, Engineering, Chemistry, Biology or related field.
• Strong knowledge of GMP/GxP and ISO 9001/13485.
• Experience with CAPA, deviation management and change control.
• Experience with validation/qualification activities.
• Excellent analytical, problem-solving and attention to detail.

Responsibilities

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

Skills

Quality Assurance

GMP/GxP Knowledge

CAPA & Deviation Management

Risk Assessment

Root Cause Analysis

Validation & Qualification

Cross-Functional Collaboration

Analytical Thinking

Communication Skills

Fluency in Norwegian & English

Education

Advanced degree in Life Sciences/Engineering/Chemistry/Biology

Tools

Quality Management Systems (QMS)

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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.

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.