(Senior) Quality Assurance Engineer Job Details | Ambu

(Senior) Quality Assurance Engineer

Are you passionate about quality and compliance within the Medical Device industry? Do you want to be a part of a global organization with high professional standards and a great working environment? Then we have an exciting job opportunity that may be your next career move.

Apply today and join us as (Senior) Quality Assurance Engineer in Deviation Controls & Reporting (Global Quality Management Operations, QM) out of our HQ in Ballerup, Denmark.

Key responsibilities
In this role, you will be part of a small team consisting of 3 talented Quality Management professionals. Together, you will ensure quality and regulatory compliance of Ambu products and processes across the organization by continuously monitoring compliance of compliance via CA/PA, NCR and Management Review.

This will include development and optimization of the Quality Management System and Processes within your team’s area of responsibility. This position will have different operational, support and improvement responsibilities, with further opportunities to impact the processes and development of QM Operations strategic journey.

Your main responsibilities will include:

• Responsible for driving CAPA/NCRs with your business partners in Ambu
• Support and drive Global Quality Management Review process, including data review from stakeholders across the organization.
• Support with communication of KPI to relevant Stakeholders
• Support the organization with Planned deviations
• Perform training in NCR/CAPA for Ambu A/S HQ.
• Participate in global quality fora to discuss proactive process improvement and support local manufacturing sites.
• Provide support in updating and revising SOPs related to the processes

Other tasks that potentially be included:
Support other processes and tasks within QM Operation, for example optimizations projects

Suggested candidate profile
Skills and experiences 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:

• Have a relevant academic background, BSc / MSc/ Engineer
• Have at least 2-10 years’ experience working in a quality organization within Medical Devices
• Experience with CAPAs, NCRs, LEAN
• Have strong knowledge of relevant regulations for medical devices e.g., ISO13485, EU MDR, MDSAP, UK MD and relevant standards
• Have a passion for quality and focus on QM business partnering with the organization
• English is the corporate language, which requires that you speak and write English at a relatively high level.

You are an outgoing and open-minded individual who thrives on learning and development. Whether working independently or as part of a team, you bring a strong sense of responsibility and collaboration. You take pride in respectful dialogue and positive interactions with colleagues across a global organization.

You are structured and methodical, with a strong ability to prioritize, plan, and see tasks through to completion. You consistently demonstrate a good balance between business needs and regulatory requirements across all key responsibilities.

In addition, you are a sharp and reliable reviewer with a keen eye for detail, ensuring high quality and accuracy in all deliverables

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.

For more information, please visit ambu.com or follow us on LinkedIn.