Senior Quality System Specialist, Global Quality Management Systems
Do you enjoy working with QMS process alignment, optimization and simplification in a global organization? Would you like to take on a Quality Management business partner role and be part of bringing QMS process excellence to the next level in Ambu? Then this position may be your next exciting opportunity
You will join the Global Quality Management Systems department in Ballerup, with colleagues located in both Ballerup and Augsburg. You will report to the Director of Global Quality Management Systems.
You will be part of a strong quality culture where Take Charge, Team Up and Stay True are our core values.
A job with global impact
As Senior Quality System Specialist, you will get a varied working day in a dynamic organization where you get to influence Ambu’s global processes as well as your own daily tasks and responsibilities. As part of the strategic ambition to “excel in execution”, the Global Quality Management Organization plays a key role in facilitating QMS process simplification and efficiencies in Ambu. In this position you will get a key role in this and collaborate with process owners and colleagues across the global organization.
Key responsibilities
- Together with your colleagues in Global QM Systems, act as Corporate subject matter expert of QMS process requirements and industry practices for effective implementation.
- Take role as QMS simplicity ambassador, communicating and facilitating a QMS simplicity mindset in Ambu
- Develop a generic QMS process improvement cookbook to set direction for a structured QMS improvement approach.
- Support QMS process owners in driving QMS process simplification in a structured way to drive efficiencies in process execution
- Take lead on / support QMS process improvement activities – both internally in Global QM Systems and in close collaboration with QMS process owners across the organization
- Collaborate closely with our Senior Training Compliance Manager to ensure a strong link between QMS process roles and related training activities.
- Perform various quality training activities.
- Participate in Notified Body audits and inspections by authorities.
- As part of the Global QM Systems department, you will have the opportunity to be involved in many different day to day activities, take process ownership of a QMS process within our area of responsibility as well as taking a role as internal / Corporate auditor in Ambu.
Suggested candidate profile
Skills and experiences can be earned in many different 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 possess:
We’re looking for someone with a solid academic foundation (BSc or MSc) and a strong professional track record in quality management within a regulated industry. You’re likely to thrive in this role if you bring:
- 6–8 years of experience working with or owning Quality Management System (QMS) processes in a regulated environment, ideally within the medical device or pharmaceutical industry, and preferably within a Quality department.
- Deep knowledge of relevant quality system standards and regulatory frameworks, such as ISO 13485, MDSAP, or similar certifications from other regulated sectors.
- Proven ability to drive structured improvements in QMS processes, with a clear focus on efficiency and simplification — whether through formal projects or ongoing optimization efforts.
- A strong appreciation for the interconnection between QMS processes and training, with experience in aligning both to support effective implementation and adoption.
- Hands-on experience conducting quality training for larger groups will be considered a significant advantage.
- Ambu is a global company, and English is our corporate language, which requires that you speak and write English at a relatively high level.
Beyond technical expertise, we’re looking for someone who brings real passion for business partnering, enjoys working across functions, and is committed to building a strong quality culture in a global organization.
And most importantly , you won’t be on this journey alone. You’ll be joining a dedicated and welcoming team that values collaboration, supports each other, and takes pride in making a meaningful impact together. If you're looking for a place where you can grow, be challenged, and truly contribute, we’d love to hear from you!
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.