Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Position Summary:
Join Thermo Fisher Scientific as a Technical Quality Engineer and contribute to global healthcare and scientific advancement. As a Technical Quality Engineer, you will play an important role in ensuring strong compliance across our quality processes. You will collaborate widely across the site, providing guidance, problem-solving support, and expertise within qualification, validation, documentation, and regulatory compliance.
You will be an active contributor in improvement initiatives, risk management activities, and cross-functional projects related to new product development and ongoing product support. This role involves close collaboration with stakeholders in Quality Assurance, Production, Engineering, and R&D.
Key Responsibilities
- Plan, execute, and document qualification and validation activities for equipment, processes, test methods, and software in compliance with regulatory and internal requirements
- Support validation lot release and ensure accurate, complete documentation
- Drive risk management activities (ISO 14971) and lead structured root cause analyses (e.g., A3, 3C, Fishbone)
- Support CAPA processes, nonconformance handling, and customer complaint investigations
- Develop and maintain product and QMS documentation (e.g., DMR, specifications, protocols, work instructions, Quality Plans) in compliance with ISO 13485 and MDR/IVDR
- Act as project manager or quality representative in development and improvement projects, collaborating cross-functionally (Production, R&D, RA, Supply Chain)
- Provide quality input for design changes, process improvements, and product lifecycle activities, including dose verification, audits, shelf-life studies, and product monitoring
- Train and guide colleagues in quality processes and promote a strong quality culture
- Drive continuous improvement initiatives (Lean/PPI) and support data-driven decision-making
- Communicate effectively with stakeholders and support audits, inspections, and audit readiness
- Perform additional tasks as needed to support the Quality organization
Requirements / Qualifications
- Min. 2 years of experience in qualification and validation
- Knowledge of ISO 13485, ISO 9001, and ISO 14971 or experience from a regulatory environment
- Strong analytical skills and a structured, detail-oriented approach
- Ability to work both independently and collaboratively in a dynamic, cross-functional environment
- Strong communication skills in English and Danish
- Strong organisational skills with the ability to manage multiple priorities
- Proficiency in Microsoft Office and Quality Management Systems
- Positive, collaborative, and inclusive mindset and strong communication & teamworking skills
- Experience with root cause analysis and continuous improvement methodologies an advantage
Preferred Background
Experience from either:
- Laboratory environments (e.g., life sciences, sterilization validation, calibration, or validation within medical device or pharmaceutical industries)
or - A technical background (e.g., technician or engineer within laboratory, process, or plastics manufacturing)
What We Offer
- Excellent development opportunities with great variety of options in which to potentially specialise
- Working closely with the business getting to know colleagues across other departments
- Ability to partake in global projects with our international colleagues
- Onsite free health clinic and good canteen
About Thermo Fisher Scientific
At Thermo Fisher Scientific, our 130,000+ employees are united by a shared mission: to enable our customers to make the world healthier, cleaner, and safer.
