Senior Quality Management R&D Specialist
Are you driven by a passion for quality? Do you bring a wealth of experience in Quality Management for Medical Device development, particularly in Medical Electrical Equipment? Are you eager to lead compliance, foster continuous improvement, and contribute to groundbreaking global R&D projects?
Your next career step could be as a Senior QM R&D Specialist at Ambu.
Why Ambu?
At Ambu, we are pioneers in the medical device industry, committed to advancing patient care worldwide. As a Senior QM R&D Specialist, you will play a vital role in expanding our Global Quality Management R&D team, embedded in a culture of collaboration, integrity, and innovation.
You'll join a growing team of 16 quality engineers located in Ballerup, Denmark, and Augsburg, Germany.
This role offers the flexibility to be based in either Ballerup or Augsburg.
Key responsibilities
As Senior QM R&D Specialist, you will 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 responsibilities will include:
- Leading global R&D project activities as the Quality Management Lead.
- Driving Risk Management activities for R&D projects.
- Acting as the go-to expert for basic safety and essential performance requirements.
- Handling and monitoring CAPA, non-conformities, and planned deviations.
- Representing Ambu during Notified Body audits and regulatory inspections.
Suggested candidate profile
Skills can be earned in different ways, however, we imagine your background entails:
- A BSc/MSc in a relevant field is required, along with at least five years of experience in a highly regulated industry.
- You bring a deep understanding of the regulatory and quality standards governing medical devices or pharma, including 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.
- Being self-driven and comfortable taking the lead, you also value collaboration, are open-minded, and adapt well to dynamic and fast-paced environments.
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.