About this role
<p style="margin:12.0pt 0.0cm;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-size:22.0pt;line-height:116%"> </span><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> <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:windowtext">Shape the Future of Medical Innovation</span></strong></h1> <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">Are you passionate about quality and compliance in medical device development? Do you have extensive experience in Quality Management across the product lifecycle—from New Product Development to Post Market Surveillance? If you're ready to lead global R&D initiatives and drive continuous improvement, your next career move could be with <strong>Ambu</strong>.</span></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:12.0pt 0.0cm;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="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.</span></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">You’ll join a growing team of 20 quality engineers based in Ballerup, Denmark and Augsburg, Germany, with this role <strong>located in Augsburg, Germany</strong></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"><strong><span style="font-family:Arial, sans-serif;color:#f82350">Key responsibilities</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 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:</span></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">Leading global R&D projects as the <strong>Quality Management Lead</strong></span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">Driving <strong>Risk Management</strong> for both new and existing products</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">Supporting <strong>Life Cycle Management</strong> activities, including design changes and post-market surveillance</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">Managing non-conformities<strong> and CAPA activities</strong></span></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:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="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</span><span style="font-family:Arial, sans-serif">a strong foundation in quality and a proactive mindset. Ideally, your profile includes:</span></p> <ul style="margin-bottom:0.0cm;margin-top:0.0px"> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">A BSc/MSc in a relevant field and <strong>5+ years of experience</strong> in a regulated industry (medical devices or pharma)</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="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></span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">Experience as a Quality Engineer in medical device development projects</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">Strong communication skills and the ability to translate quality requirements into actionable strategies</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">A collaborative, open-minded approach with the confidence to drive and adapt in a fast-paced environment</span></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:0.0cm 0.0cm 0.0cm 0.0px;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">Opportunities for personal and professional development</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">A dynamic, diverse and international work environment</span></li> <li style="margin:0.0cm 0.0cm 0.0cm 0.0px;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"><span style="font-family:Arial, sans-serif">A wide range of employee benefits—professional, social, and financial</span></li> </ul> <p style="margin:0.0cm;line-height:116%;font-size:12.0pt;font-family:Aptos, sans-serif"> </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"> </p> <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="text-align:justify;margin:0.0cm 0.0cm 8.0pt;line-height:116%;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"> </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">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>