Head of QMS Processes
Join Ambu in shaping the future of healthcare through quality excellence.
Ambu is currently looking for an experienced leader to head our QMS processes department. This position plays a central part in ensuring the foundation of an efficient and well-functioning Quality Management System for Ambu globally. The department has also key role in securing licenses to operate through Ambu certification process.
You will lead the development of global capabilities, drive strategic initiatives, ensure regulatory compliance, and foster strong cross-functional partnerships across Ambu’s international organization.
QMS Processes is a new department within Global Quality Management Systems area. The position reports to the Director of Global Quality Management Systems, and is based at our HQ in Ballerup, Denmark.
In this role, you will lead a stellar team consisting of currently 7 talented QM (senior) professionals. Together, you will ensure quality and regulatory compliance of Ambu products and processes across the organization by continuously monitoring compliance.
This will include development and optimization of the Quality Management System and Processes within your team’s area of responsibility. Moreover, you will be accountable for the Audit Management globally.
Your main responsibilities will include:
- Daily manager of the Department QMS Processes in Ambu (Quality Manual & QMS Process Landscape, Quality Audits, Quality Planning, Change Control, Certifications, Document and Records Management, Good Documentation Practice, Post Market Surveillance)
- Implement effective global processes, with optimal balance between global and local responsibility
- Ensure a high degree of scalability, which means that the process of adding (or removing) sites covered by the Quality Management System can be done with a minimum of changes to the existing QMS
- Responsible for coordinating proactive solutions to global challenges to Ambu Quality Systems.
- Ensure monitoring of Global QMS system to ensure continued compliance and efficiency - and act when non-conformities are identified
- Ensure know-how center for quality management system issues, and ensure proper implementation through education and assistance to the organization
- Educate the organization on the importance of QMS
- Ensure Internal Audit Plans and Corporate Audit Plans are executed, manage and participate in internal audit (audit coordination)
- Planning and leading External audits in collaboration with colleagues in GQM Systems
- Assist in contact with external auditors
- Host and participate during inspections from authorities.
- Responsible for GQM participation in Audits.
- Assist in selected projects within QMS area.
- Support other processes and tasks within GQM Systems.
- Responsible for driving Post Market Surveillance process
- Responsible for continuous improvement of the process
- Responsible for ensuring process is in compliance with regulatory requirements
- Responsible for facilitating the timely performance of PMS plans and reports
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:
- Expected 10 years of professional experience in quality management, or related areas, with at least 5 years in a leadership role
- Proven experience working within the medical device industry, with deep understanding of its regulatory and operational landscape
- Strong knowledge of global regulatory standards, including FDA, ISO 13485, and other applicable frameworks
- Experience in building and managing quality systems and processes
- A bachelor’s or master’s degree in a relevant field (e.g., engineering, life sciences, quality management), or equivalent education and experience
- Excellent leadership, communication, and stakeholder management skills, with the ability to drive change and resolve complex challenges
- Fluency in English, both written and spoken
- Ability to work from our Ballerup (Denmark) HQ office, with flexibility to work from home up to two days per week
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.
If you have any questions about the position, you can contact Director of GQM Systems Niels-Jørgen Svarrer, at nisv@ambu.com
Your application will be treated with confidentiality.
About Ambu
Ambu has been bringing 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