Quality Assurance Engineer

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Ballerup

Are you passionate about quality and do you want to be part of a global organization with high professional standards working to shape the future of medical devices?
Then we have an exciting job opportunity that may be your next career move.
We are looking for a pragmatic and professional quality engineer

You will be part of a strong quality culture, where we keep ahead of new regulatory requirements and continuously strive for improvements. You will work from our Headquarters in Ballerup, Denmark and join a Corporate Quality Engineering unit where you will refer to the Manager of QAE Life Cycle Management.

A global job with impact
As Quality Assurance Engineer, you will get a varied working day in a dynamic organization where you get to influence Ambu’s marketed products as well as your own daily tasks and responsibilities.

Your key responsibilities will be to:

  • Be process responsible for the Post Market Surveillance process, in collaboration with your colleagues.
  • Be involved in the Customer complaint process together with your colleagues
  • Continuously develop the Quality Assurance Engineering area, including ensuring efficient QMS processes within your own area of responsibility
  • Review and approve post market product activities, e.g., design control review
  • As a corporate function, ensuring a global quality overview
  • Be part of a cross-functional team, and you will be working closely together with stakeholders from Regulatory Affairs, R&D, Marketing, Clinical Department and Ambu manufacturing sites.


We expect you to be structured, open-minded and see possibilities.

You probably have a MSc or similar within biological, biomedical, mechanical, or chemical engineering.

To succeed in the job, you preferable have experience within the Quality Assurance or perhaps QC work, nonconformities, CAPA and COA/COC release within Medical Device industry.

Furthermore, it is an advance that you have knowledge and experience with ISO13485, 21CRF820 and EU MDR 2017/745.

You have excellent communication skills, and you can take lead of cross-functional tasks. You have experience with working in a high paced environment and you are not afraid to take responsibility. Your business understanding makes you able to translate regulatory and quality requirements into effective business processes.

Ambu – a visionary and international workplace where your effort matters

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 a wide range of professional, social, and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.
Ambu is a global company and English is our corporate language, which requires that you speak and write English at a relatively high level. You will use English every day in your job. 

How to apply
If you are ready to apply for the position, please apply as soon as possible. Note that we will invite candidates for interviews on a continuous basis so no need to hesitate. This job ad might be online until 1st of May, but once we have found the right candidate, this ad will no longer be online.

If you have any questions about the position, you can contact Emma Snefeldt, Manager QAE Life Cycle Management, Corporate Quality Engineering, by phone +45 22435751

Your application will be treated with confidentiality.

#LI-AM1


Information og data

Denne ledige stilling har jobtypen "Produktchef", og befinder sig i kategorien "Ledelse og personale".

Arbejdsstedet er beliggende i Ballerup.

Jobbet er oprettet på vores service den 5.4.2022, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Produktchef
  • Ballerup

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