Senior Quality Systems Specialist - Digital Transformation

Job Description

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Senior Quality Systems Specialist - Digital Transformation

City:  Ballerup, Denmark

Country/Region:  Denmark

State: 

Business Area:  Quality Assurance

Department:  Digital Quality Management

Employment Type:  Full-time

Req ID:  10156

Senior Quality Systems Specialist - Digital Transformation

Are you passionate about quality and compliance within the Medical Device industry? Do you have a true passion for Quality business partnering and thriving in a process and project-oriented environment?

Then we have a new exciting job opportunity that may be your next career move.

A global job with impact:

We are looking for a Senior Quality Systems Specialist – Digital Transformation to take on this exciting role in our Global Quality Management (GQM), Digital Quality Management department, based at our headquarters in Ballerup, Denmark. You will be part of a collaborative and supportive GQM team, working with engaged and knowledgeable colleagues located both at HQ and across our global sites, where knowledge sharing and teamwork are highly valued.

Ambu is starting a new journey with the implementation of a new QMS and Product Lifecycle Management system in a new IT environment. In this role, your main responsibility will be to manage the project for this implementation within the GQM organization, ensuring that all project activities are executed in a structured, high‑quality, and timely manner in line with the project plan. The primary focus will be on Line of Business (LoB) processes.

You will work closely with committed and supportive stakeholders and colleagues across Global Quality Management, Line of Business teams worldwide, and Global IT, having full oversight of project deliverables. Collaboration, open dialogue, and a constructive team spirit are key elements of how we work together to achieve shared success.

Key responsibilities

• Co‑lead the development and implementation of Ambu’s new Quality Management System, working closely with the Program Project Manager and colleagues in Global Quality Management.
• Act as a Quality Subject Matter Expert, ensuring the system meets both business needs and regulatory requirements, while guiding the transition from the current setup to the future state.
• Design and shape future‑proof, scalable processes together with process experts, supporting growing complexity and evolving regulatory expectations.
• Collaborate with stakeholders across Ambu globally to ensure the system is well integrated, user‑friendly, and fit for purpose, including facilitating workshops, gap analyses, and alignment activities.
• Support change management, training, and communication, ensure compliance and internal governance, and contribute to the ongoing maintenance of the system after implementation in close collaboration with GQM IT QA and Global IT.

About you

Skills and experience can be gained in many ways, and we know the perfect profile cannot be prescribed on paper. You are, however, likely to succeed in this role if you bring many of the following: 

• You bring a Bachelor’s or Master’s degree in Engineering, Quality Management, Systems Engineering, or a related field, along with at least 5 years of hands-on experience in quality systems development, quality assurance, or process management within a regulated industry such as Medical Devices or Pharma. You have a solid understanding of quality and process frameworks (e.g. ISO 13485), risk‑based thinking, and continuous improvement.
• You have experience working with or implementing digital quality or process management tools, including exposure to IT system validation in a regulated environment, and are comfortable working in project-based settings, collaborating closely with both Quality and IT stakeholders.
• You are confident navigating and driving initiatives across cross-functional and global teams, bringing a structured and analytical mindset, strong problem‑solving skills, and a proactive, forward‑looking approach to your work.
• You communicate clearly and effectively, engage well with stakeholders at different levels, and are fluent in English, both written and spoken.

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 Niels-Jørgen Svarrer, Director, Global Quality Management Systems at nisv@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.