Quality System Engineer, IT Compliance

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Join us in shaping the future of Ambu Medical Devices

Are you passionate about quality? Do you like to work with Quality Assurance, continuous improvement of processes and IT systems? 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.

Ambu develop, manufacture and sell Medical Devices. Millions of patients and healthcare professionals depend on the functionality and performance of Ambu’s products worldwide. Come join a fast growing and exciting Medical Device company with an ambitious strategy.

We are looking for a Quality System Engineer, who can take up this position in the Corporate QA Systems department. You will work within the department focus area “Agile & Computerized Systems Compliance”, but also collaborate with the other focus area in the department; “QMS & Audit”.

You will be part of a strong quality culture where collaboration, integrity and results with speed are our core values.

A global job with impact

As Quality System Engineer, you will get a varied working day in a dynamic organization where you get to influence Ambu’s processes and IT Systems as well as your own daily tasks and responsibilities.

Your key responsibilities will be to:

  • Perform QA review and approval of IT changes related to various corporate IT Systems.
  • Participate as QA representative in Business IT projects for implementation, upgrades, improvements & roll-out of global Ambu GxP Business systems.
  • Maintain and continuously improve QMS processes within Corporate QA Systems area of responsibility, including improvements of Ambu’s use of the Agile Product Lifecycle Management System (PLM)
  • Act as change analyst in Agile PLM

Experience and passion
To succeed in the job, you must have a relevant academic background - e.g. a MSc / BSc in engineering or similar. You have 2-4 years’ experience from working within a Quality Assurance department or an IT department within the regulated industry.

You have;

  • Flair for working in, IT Systems as well as technical interest.
  • Experience with computerized system compliance, IT validation and IT changes for GxP systems.
  • Experience with, or interest in, QA support to IT projects and changes.
  • Knowledge of regulatory requirements for Medical Devices and computerized systems validation.

As a person, you are outgoing, open to learn, and you can work both in groups and independently. You are structured and good at prioritizing, planning and finalizing your tasks.

You take pride in good collaboration and focus on respectful dialogue with your colleagues.

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 – 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.

How to apply
If you are interested in the position, please apply as soon as possible. Note that candidates will be evaluated and invited for interviews on a continuous basis. This job ad might be online until September 30, 2021, 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 Director of Corporate QA Systems, Vibeke Lillie Gadsbøll, telephone no. +45 22 34 24 14.

Your application will be treated with confidentiality.

#LI-AM1


Information og data

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Jobbet er oprettet på vores service den 30.8.2021, 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.
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