Inserat online seit: Veröffentlicht vor 5 Std.
<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">Software Development</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>
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<p><span style="font-family:arial, helvetica, 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 Software Development? </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">As Senior QM R&D Engineer – Software Development, you will play a key role in ensuring that software and AI-enabled medical device solutions are developed, maintained, and improved in compliance with global regulatory and quality requirements. You will act as the Quality partner for software development projects and help drive excellence across the full product life cycle - from concept and development to release, maintenance, and post-market activities. </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">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>
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<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="font-family:arial, helvetica, sans-serif"><strong><span style="font-size:12.0pt;line-height:116%;color:#f82350">Why Join Ambu?</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"><span style="font-size:12.0pt">Ambu is a global leader in medical device innovation, dedicated to improving patient care. At Ambu, we are advancing our ambition to achieve global leadership in endoscopy. As part of our ZoomAhead strategy, EndoIntelligence is a central part as a unified platform that combines hardware, software, and AI to deliver integrated endoscopy solutions across the full procedure journey. Software is a core part, enabling intelligent, connected solutions that improve patient care and clinical outcomes. As a Senior QM R&D Engineer Software Development, you’ll be part of a collaborative, forward-thinking team that values integrity, innovation, and impact. </span></p>
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<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></p>
<p style="margin:0.0cm 0.0cm 8.0pt;line-height:107%;font-size:11.0pt;font-family:Arial, sans-serif"><span style="font-size:12.0pt">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. </span></p>
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<p>You’ll join a growing team of more than 42 quality engineers based in Ballerup, Denmark, Augsburg, Germany and Penang, Malaysia, with this role<strong> </strong><strong>located in Augsburg, Germany </strong></p>
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<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>
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<p><span style="font-family:arial, helvetica, 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>
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<p><span style="font-family:arial, helvetica, sans-serif">Acting as the <strong>Quality Management partn</strong><strong>er for software development and AI-related R&D projects </strong> </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">Driving and supporting<strong> </strong><strong>risk management</strong> activities for software-based and software-enabled medical devices </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">Ensuring compliance across the <strong>software life cycle</strong>, including development, verification, validation, release, maintenance, and change control </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">Supporting the integration of <strong>cybersecurity</strong> into product development and maintenance processes </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">Providing quality oversight for <strong>AI-enabled medical device software</strong>, including lifecycle controls, documentation, traceability, and change management </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">Supporting <strong>design control</strong>, <strong>life cycle management, design changes</strong><strong>,</strong> and <strong>post-market surveillance activities</strong></span></p>
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<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>
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<p><span style="font-family:arial, helvetica, 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: </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">A <strong>BSc or MSc</strong> in Software Engineering, Computer Science, Biomedical Engineering, Quality Engineering, or another relevant technical discipline </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif"><strong>Several years (5+) </strong>of experience in <strong>Quality Engineering / Quality Management </strong>within the medical device, digital health, health software, or another highly regulated industry </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">Hands-on experience working with <strong>software development projects </strong>in regulated environments </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">Solid knowledge of <strong>Software as a Medical Device (SaMD) </strong>and/or software embedded in medical devices </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">Experience with <strong>AI-enabled products</strong> or a strong understanding of quality and regulatory expectations for AI/ML-based medical software </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">Strong understanding of<strong> risk management</strong>, including both safety risk and cybersecurity risk </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">Experience working with global cross-functional teams and translating quality requirements into business-relevant, actionable guidance </span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">In-depth knowledge of standards such as <strong>IEC 62304, ISO 14971, IEC 81001-5-1, ISO 13485, EU MDR, MDSAP, UK MD, QMSR </strong></span></p>
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<p><span style="font-family:arial, helvetica, sans-serif">Understanding of the<strong> EU AI Act </strong>implications for high-risk AI systems in health/medtech is a strong advantage.</span> </p>
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<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>
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<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:12.0pt">A great Team that thrives on collaboration and values different perspectives and fosters innovation</span></li>
<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:12.0pt">Opportunities for personal and professional development</span></li>
<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:12.0pt">A dynamic, diverse and international work environment</span></li>
<li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:8.0pt;line-height:107%;font-size:12.0pt;font-family:Arial, sans-serif"><span style="font-size:12.0pt">A wide range of employee benefits—professional, social, and financial</span></li>
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<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>
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<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>
