(Senior) Manager Quality Management R&D

Are you driven by a passion for quality? Do you bring a wealth of experience in Quality Management for Medical Device, particularly in Life Cycle Management? Are you eager to lead a fantastic team to foster continuous improvement of the global Product Portfolio, and contribute to groundbreaking global R&D projects?

Your next career step could be as a (Senior) Manager Quality Management R&D at Ambu.

Why Ambu?

At Ambu, we are pioneers in the medical device industry, committed to advancing patient care worldwide. As a (Senior) QM Manager, you will play a vital role in expanding our Global Quality Management R&D team, embedded in a culture of collaboration, integrity, and innovation. The whole Team consisting of currently 16, is covering a variety of activities such as:

• Quality Management Lead and go to person in global R&D project activities (incl. Risk Management)
• Life Cycle Management (Design Changes, Post Market Surveillance)
• Complaint Investigations
• Handling and monitoring CAPA, non-conformities, and planned deviations.
• Representing Ambu during Notified Body audits and regulatory inspections.

At Ambu, we believe that collaboration and teamwork are essential to our success. This role fosters a collaborative environment where two teams and their managers work closely together, aligning on agendas, tasks, and goals. Flexibility and adaptability are key, as all team members are involved in the mentioned activities to ensure we meet our dynamic and fast-paced environment's demands. 

Key responsibilities

As (Senior) Manager QM R&D, you will be a people manager of 1 of the 2 QM R&D Teams with 8 direct reports located in Ballerup, Denmark, and Augsburg, Germany.

This role will be based in Ballerup, Denmark.

You get a varied working day in a dynamic organization where you get to influence Ambu’s processes as well as your own daily tasks and responsibilities.

In this position, you’ll enjoy a dynamic work environment where your impact extends across projects and processes.

Your main responsibility will include:

• The oversight and coordination of LCM activities (Design Changes, Post Market Surveillance).
• Coordination and Alignment of LCM and New Development Project activities within the QM R&D Management Team.
• Handling and monitoring CAPA, non-conformities, and planned deviations.
• Representing Ambu during Notified Body audits and regulatory inspections.
• People Management.

Suggested candidate profile

Skills can be earned in different ways; however, we imagine your background entails:

• You are characterized by a pragmatic leadership with a high focus on collaboration and teamwork in a truly global environment.
• Have led teams within a highly regulated area.
• You bring a deep understanding of the regulatory and quality standards governing Medical Devices or Pharma, including Life Cycle Management (such as Post Market Surveillance), Risk Management, Quality Management Systems, and safety requirements (such as ISO 14971, ISO 13485, EU MDR, MDSAP, and UK MD).
• A passion for quality and a focus on QM business partnering with the organization are essential.
• As a person, you are outgoing, have a strong business understanding, and excel in communicating quality requirements while facilitating effective implementation within a global organization.
• Can keep your eyes on the target and being able to zoom-out, you also value collaboration, are open-minded, and adapt well to dynamic and fast-paced environments.

Please note, depending on the applicants’ professional experience the position will be defined as a Manager or a Senior Manager. 

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.