Design Quality Assurance Specialist

<p style="text-align:left"><b>Work Schedule</b></p>Standard (Mon-Fri)<p style="text-align:inherit"></p><p style="text-align:left"><b>Environmental Conditions</b></p>Office<p style="text-align:inherit"></p><p style="text-align:left"><b><u>Job Description</u></b></p><p style="text-align:inherit"></p><p>At Thermo Fisher Scientific, our Mission is to enable our customers to make the world healthier, cleaner and safer.</p><p></p><p>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 120,000 colleagues worldwide, we are the world leader in serving science.</p><p></p><p></p><h2>Make an impact where science meets purpose</h2><p></p><p>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.</p><p>Here, your work directly supports clinicians in delivering more accurate diagnoses and better patient outcomes around the world.</p><p></p><p>We are now looking for a <b>Design Quality Specialist</b> to join our ImmunoDiagnostics team in Uppsala.</p><p></p><p></p><h2>How you will make an impact</h2><p></p><p>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.</p><p></p><p>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.</p><p></p><p>This role reflects who we are:</p><ul><li><p>A transformative leader powered by an important Mission</p></li><li><p>A company that believes in working the right way for the right reasons</p></li><li><p>A place where careers are made</p></li></ul><p></p><p></p><h2>What you will do</h2><ul><li><p>Act as a core Quality representative in product development projects</p></li><li><p>Ensure design controls are defined, implemented and followed</p></li><li><p>Guide teams in applying applicable quality processes throughout development</p></li><li><p>Participate in and contribute to design reviews and key design record assessments</p></li><li><p>Take ownership of assigned quality processes such as risk management or post-market surveillance</p></li><li><p>Drive continuous improvement of quality processes</p></li><li><p>Train and support colleagues in quality management system requirements</p></li><li><p>Prepare for and participate in external audits</p></li></ul><p></p><p>You will collaborate closely with R&amp;D, Regulatory, Operations and other cross-functional teams, helping translate quality requirements into practical, efficient solutions.</p><p></p><p></p><h2>What you bring</h2><ul><li><p>University degree in medical or technical sciences</p></li><li><p>Significant experience working with Quality Management Systems in an IVD or medical device environment (e.g., QSR, EU MDR/IVD regulations, ISO 13485)</p></li><li><p>Experience with product development and design controls</p></li><li><p>Strong analytical and problem-solving capabilities</p></li><li><p>Proven ability to drive tasks and projects to timely completion</p></li><li><p>Excellent communication skills in Swedish and English</p></li><li><p>Strong interpersonal skills and the ability to build trust across functions</p></li></ul><p></p><p>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.</p><p></p><h2>Why join us in Uppsala?</h2><ul><li><p>Be part of a global leader in allergy and autoimmune diagnostics</p></li><li><p>Contribute to products that impact millions of patients worldwide</p></li><li><p>Work in a highly collaborative and science-driven environment</p></li><li><p>Grow your career in a company where development and mobility are encouraged</p></li></ul><p></p><p>At Thermo Fisher Scientific, you will be empowered to reimagine your career journey while contributing to work that truly matters.</p><p></p><p>If you’re ready to combine scientific rigor, regulatory excellence and meaningful patient impact — we would want to hear from you!</p><p></p><p>Please apply as soon as possible, the position will be filled as soon as suitable candidate is found.</p><p></p><p></p><p></p><p></p>