About this role
<p style="margin:12.0pt 0.0cm;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif;text-align:center"><strong><span style="font-size:22.0pt;line-height:116%;font-family:Arial, sans-serif;color:#f82350">Senior Quality Management R&D Engineer</span></strong></p> <p style="margin:12.0pt 0.0cm;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif;text-align:center"><strong><span style="font-size:22.0pt;line-height:116%;font-family:Arial, sans-serif;color:#f82350">Risk Management</span></strong></p> <h1 style="margin:12.0pt 0.0cm 0.0cm;line-height:116%;font-size:16.0pt;font-family:'Aptos Display', sans-serif;color:#0f4761;font-weight:normal"><span style="background-color:#ffffff;color:#e33b3b"><strong><span style="font-size:12.0pt;line-height:116%;font-family:Arial, sans-serif;background-color:#ffffff">Shape the Future of Medical Innovation</span></strong></span></h1> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Are you passionate about quality and compliance in medical device development? Do you have extensive experience in Quality Management across the product lifecycle— especially in Risk Management? If you're ready to lead global R&D initiatives and drive continuous improvement, your next career move could be with <strong>Ambu</strong>.</p> <h1 style="margin:12.0pt 0.0cm 0.0cm;line-height:116%;font-size:16.0pt;font-family:'Aptos Display', sans-serif;color:#0f4761;font-weight:normal"><strong><span style="font-size:12.0pt;line-height:116%;font-family:Arial, sans-serif;color:#f82350">Why Join Ambu?</span></strong></h1> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Ambu is a global leader in medical device innovation, dedicated to improving patient care. As a (Senior) QM R&D Engineer, you’ll be part of a collaborative, forward-thinking team that values integrity, innovation, and impact.</p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"> </p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><strong><span style="font-family:Arial, sans-serif;color:#f82350">Join a Team That Thrives on Collaboration and Diversity</span></strong><br>We offer a dynamic and supportive team environment where mutual trust and collaboration are at the heart of everything we do. Our team brings together talented professionals from across the globe, creating a truly international workplace that values different perspectives and fosters innovation. If you are looking for a role where teamwork, inclusivity, and shared success define the culture, this is the place for you.</p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">You’ll join a growing team of more than 40 quality engineers based in Ballerup, Denmark, Augsburg, Germany and Penang, Malaysia, with this role <strong>located in Augsburg, Germany or Ballerup, Denmark</strong></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Arial, sans-serif;color:#f82350">Key responsibilities</span></strong></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">As a Senior QM R&D Engineer, you’ll play a pivotal role in shaping Ambu’s quality processes and driving excellence across global sites. Your key responsibilities include:</p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Driving <strong>Risk Management</strong> for both new and existing products</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Being the <strong>Quality Management</strong> partner for global R&D projects</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Carry out <strong>Life Cycle Management</strong> activities, including design changes and post-market surveillance</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Supporting non-conformities<strong> and CAPA activities</strong></li> </ul> <p style="margin:12.0pt 0.0cm;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Arial, sans-serif;color:#f82350">Suggested candidate profile</span></strong><span style="font-family:Arial, sans-serif"> </span></p> <p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Skills and experiences can be earned in many ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you have a strong foundation in quality and a proactive mindset. Depending on your previous experience this role can also be a Senior position. Ideally, your profile includes:</p> <ul style="margin-top:0.0cm;margin-bottom:0.0cm" type="disc"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">A BSc/MSc in a relevant field and <strong>3+ years of experience</strong> in a regulated industry (medical devices or pharma)</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">In-depth knowledge of standards such as <strong>ISO 14971</strong>, <strong>ISO 13485</strong>, <strong>EU MDR</strong>, <strong>MDSAP</strong>, and <strong>UK MD</strong></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Experience as a Quality Engineer in Research & Development projects of medical devices</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Strong communication skills and the ability to translate quality requirements into actionable strategies</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">A collaborative, open-minded approach with the confidence to drive and adapt in a fast-paced environment</li> </ul> <p style="margin:12.0pt 0.0cm;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Arial, sans-serif;color:#f82350">We offer:</span></strong></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">A great Team that thrives on collaboration and values different perspectives and fosters innovation</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">Opportunities for personal and professional development</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">A dynamic, diverse and international work environment</li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif">A wide range of employee benefits—professional, social, and financial</li> </ul> <p style="margin:12.0pt 0.0cm;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Arial, sans-serif;color:#f82350">Ready to Apply?</span></strong></p> <p style="margin:12.0pt 0.0cm;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis.. Interviews are conducted on a rolling basis, so don’t wait—<strong>apply today</strong> and help us shape the future of patient care.</span></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:12.0pt;font-family:Aptos, sans-serif"> </p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Arial, sans-serif;color:#f82350">About Ambu</span></strong></p> <p style="margin:0.0cm;text-align:justify;line-height:normal;background-color:white;font-size:12.0pt;font-family:Aptos, sans-serif"><strong><span style="font-family:Arial, sans-serif;color:#f82350"> </span></strong></p> <p style="text-align:justify;margin:0.0cm 0.0cm 8.0pt;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">Ambu has been bringing their solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.</span></p>