Senior Quality Management R&D Engineer (m/w/d)

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. Shape the Future of Medical Innovation 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 Ambu. Why Join Ambu? 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. You'll join a growing team of 20 quality engineers based in Ballerup, Denmark and Augsburg, Germany, with this role located in Augsburg, Germany
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: Leading global R&D projects as the Quality Management Lead Driving Risk Management for both new and existing products Supporting Life Cycle Management activities, including design changes and post-market surveillance Managing non-conformities and CAPA activities
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 havea strong foundation in quality and a proactive mindset. Ideally, your profile includes: A BSc/MSc in a relevant field and 5+ years of experience in a regulated industry (medical devices or pharma) In-depth knowledge of standards such as ISO 14971, ISO 13485, EU MDR, MDSAP, and UK MD Experience as a Quality Engineer in medical device development projects Strong communication skills and the ability to translate quality requirements into actionable strategies A collaborative, open-minded approach with the confidence to drive and adapt in a fast-paced environment
Opportunities for personal and professional development A dynamic, diverse and international work environment A wide range of employee benefits—professional, social, and financial