Quality Assurance Engineer

Job Description

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Quality Assurance Engineer

City:  Ballerup

Country/Region:  Denmark

State: 

Business Area:  Quality Assurance

Department:  Global Quality Management Deviation Control & Reporting

Employment Type:  Full-time

Req ID:  10125

Quality Assurance Engineer

Are you passionate about quality and compliance within the Medical Device industry? Do you want to be a part of a global organization with high professional standards and a great working environment? Then we have a new exciting job opportunity that may be your next career move. 

Would you like to join a global organization where collaboration, professionalism, and a supportive team culture truly matter? Then apply today and join us as Quality Assurance Engineer to take responsibility for our CAPA Process.

 This new position is placed in Deviation Controls & Reporting (Global Quality Management Operations, QM) out of our site in HQ in Ballerup, Denmark. 

Key responsibilities 

You will join a small, experienced, and supportive team of 7 quality professionals who work closely together and value knowledge sharing, open dialogue, and helping each other succeed.

In this role, you will work both operationally and strategically, driving optimization initiatives within Quality Management in collaboration with stakeholders across the organization. You will play an important part in ensuring quality and regulatory compliance of Ambu’s products and processes, while also contributing to the continuous development of our Quality Management System and ways of working.

The role offers a good balance between hands‑on responsibilities and the opportunity to influence processes, improvements, and the future direction of QM Operations.

Your main responsibilities will include: 

Tasks will include: 

• Cross-functional teamwork and driving Improvement Projects

• Communication to Management and other relevant stakeholders

• Engage in global quality forums to promote proactive process improvements and provide support to local manufacturing sites.

• Driving monitoring quality issues across interconnected processes in order identify potential quality action, for example through customer complaints.

• Driving updating and revising SOPs related to the processes

Other tasks that potentially be included: 

Support other processes and tasks within QM Operation, for example optimizations projects. 

Suggested candidate profile 

Skills and experience 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 posses: 

• A relevant academic background (BSc / MSc / Engineering)
• 3–5 years of experience in a quality role within the Medical Device industry
• Experience with Management Review, LEAN principles, and project management
• Experience developing KPIs, monitoring performance, and using data to support decision‑making and continuous improvement
• Solid knowledge of medical device regulations and standards (e.g. ISO 13485, EU MDR, MDSAP, UK MDR)
• A genuine interest in quality and a collaborative, business‑partner mindset
• Strong English skills (spoken and written), as English is our corporate language

Your personal style

You are open‑minded, curious, and motivated by learning and development. You feel comfortable working both independently and as part of a team, and you value respectful collaboration with colleagues across functions and geographies.

You are structured and methodical, with the ability to prioritize effectively and follow tasks through to completion, always balancing business needs with regulatory requirements. Known for your attention to detail, you take pride in delivering high‑quality, reliable work.

Ambu – a visionary and international workplace where your efforts matter 

 Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment. 

 We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development. 

 When 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 so there is no need to hesitate. 

If you have any questions about the position, you can contact Nina Brink Katz, Quality Manager, Deviation Controls & Reporting • Global Quality Management Operations at nink@ambu.com

About Ambu

Ambu has been bringing the 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.

For more information, please visit ambu.com or follow us on LinkedIn.