Design Quality Assurance Specialist

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific our Mission is to enable our customers to make the world healthier cleaner and safer.

Every day our colleagues help advance life-saving research support clinical breakthroughs and ensure the safety of our food and environment. With more than $40 billion in annual revenue and over 120000 colleagues worldwide we are the world leader in serving science.

Make an impact where science meets purpose

In Uppsala our teams develop manufacture and market complete blood test systems that support the clinical diagnosis and monitoring of allergy asthma and autoimmune diseases. We are the global leader in in-vitro allergy testing and a European leader in autoimmunity diagnostics.

Here your work directly supports clinicians in delivering more accurate diagnoses and better patient outcomes around the world.

We are now looking for a Design Quality Specialist to join our ImmunoDiagnostics team in Uppsala.

How you will make an impact

As a Design Quality Specialist you will play a critical role in ensuring that our product development projects meet the highest standards of quality compliance and patient safety.

You will serve as a core team member in cross-functional product development projects representing Quality and guiding teams through design controls and regulatory requirements. Your expertise will help ensure that innovative diagnostic solutions are developed the right way for the right reasons.

This role reflects who we are:

• A transformative leader powered by an important Mission

• A company that believes in working the right way for the right reasons

• A place where careers are made

What you will do

• Act as a core Quality representative in product development projects

• Ensure design controls are defined implemented and followed

• Guide teams in applying applicable quality processes throughout development

• Participate in and contribute to design reviews and key design record assessments

• Take ownership of assigned quality processes such as risk management or post-market surveillance

• Drive continuous improvement of quality processes

• Train and support colleagues in quality management system requirements

• Prepare for and participate in external audits

You will collaborate closely with R&D Regulatory Operations and other cross-functional teams helping translate quality requirements into practical efficient solutions.

What you bring

• University degree in medical or technical sciences

• Significant experience working with Quality Management Systems in an IVD or medical device environment (e.g. QSR EU MDR/IVD regulations ISO 13485)

• Experience with product development and design controls

• Strong analytical and problem-solving capabilities

• Proven ability to drive tasks and projects to timely completion

• Excellent communication skills in Swedish and English

• Strong interpersonal skills and the ability to build trust across functions

You are a collaborative team player who thrives in a cross-functional environment and takes pride in ensuring quality is embedded from concept to launch.

Why join us in Uppsala

• Be part of a global leader in allergy and autoimmune diagnostics

• Contribute to products that impact millions of patients worldwide

• Work in a highly collaborative and science-driven environment

• Grow your career in a company where development and mobility are encouraged

At Thermo Fisher Scientific you will be empowered to reimagine your career journey while contributing to work that truly matters.

If youre ready to combine scientific rigor regulatory excellence and meaningful patient impact we would want to hear from you!

Please apply as soon as possible the position will be filled as soon as suitable candidate is found.