Senior QM R&D Engineer - Risk Management

City: Ballerup, Augsburg

Country/Region: Denmark, Germany

State:

Business Area: Quality Assurance

Department: Global Quality Management R&D

Employment Type: Full-time

Req ID: 10344

Senior Quality Management R&D Engineer

Risk Management

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— 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 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.

Join a Team That Thrives on Collaboration and Diversity
We offer a collaborative 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.

You’ll join a growing team of more than 40 quality engineers based in Ballerup, Denmark, Augsburg, Germany and Penang, Malaysia, with this role located in Augsburg, Germany or Ballerup, Denmark

Key responsibilities
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:

• Driving Risk Management for both new and existing products
• Being the Quality Management partner for global R&D projects
• Carry out Life Cycle Management activities, including design changes and post-market surveillance
• Supporting non-conformities and CAPA activities

Suggested candidate profile
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:

• A BSc/MSc in a relevant field and relevant 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 Research & Development projects of medical devices
• 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

We offer:

• A great Team that thrives on collaboration and values different perspectives and fosters innovation
• Opportunities for personal and professional development
• A dynamic, diverse and international work environment
• A wide range of employee benefits—professional, social, and financial

Ready to Apply?
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— apply today and help us shape the future of patient care.