Senior-Quality-Assurance-Engineer

Senior Quality Assurance Engineer

Are you excited by 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 Global Quality Management Operations out of our HQ in Ballerup, Denmark – driving our Post Market Surveillance process to the next level.

Key responsibilities
In this role, you will be part of a stellar team consisting of 10 talented QM professionals. Together, you will ensure quality and regulatory compliance of Ambu products and processes across the organization by continuously monitoring compliance via CA/PA, NCR, SQM, Intelligence reporting etc.

Supporting our strategic journey in QM Operations we are looking for a strong candidate to drive and further develop and improve our Post Market Surveillance process together with our stakeholders in Global Quality Management and primarily R&D.

Your main responsibilities will include:

• Responsible for driving Post Market Surveillance with your business partners in Ambu
  • 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
• Overall improvement of the Quality System Performance within QA Processes
• Participate in global quality fora to discuss proactive process improvement
  

Other tasks that potentially be included or be involved in:

• Support other processes and tasks within QM Operation

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:

Have a relevant academic background, BSc / MSc/ Engineer

• Have at least 5-10 years’ experience working in a quality organization within Medical Devices
• Carry demonstrated experience with Post Market Surveillance
• 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

As a person, you are outgoing, open to learn, and you can work both in groups and independently. You take pride in good collaboration and focus on respectful dialogue with your colleagues. You are structured and good at prioritizing, planning, and finalizing your tasks. For all the key responsibilities you can establish good balance between business requirements and requirements from regulations.

Ambu is a global company and English is our corporate language, which requires that you speak and write English at a relatively high level.

Ambu promise.

• The chance to actively help shape a paradigm shift in the healthcare market.
• An exciting job with innovative and groundbreaking medical device products.
• A pleasant working atmosphere where the customer is the focus of our work.
• A collegial, friendly and dynamic working environment in a constantly growing company.
• Participation in an energetic team with short communication channels.
• Remuneration in line with the market and performance.
• Room for active personal and professional advancement.

How 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.

If you have any questions about the position, you can contact Head of Global Quality Management Operations and IT Compliance Niels-Jørgen Svarrer, at [email protected]

Your application will be treated with confidentiality.

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.