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QA Professional
QA/RA

Join us to shape the future of medical devices

Are you passionate about quality? Do you like to work with continuous improvements of business processes? Do you have experience with medical devices, quality management systems and IT systems?

Do you want to be a part of a truly global organisation with high professional standards and a great working environment?

Then we have an exciting job opportunity that may be your next career move…

Ambu develops, manufactures and sells medical devices. Millions of patients and healthcare professionals depend on the functionality and performance of Ambu’s products worldwide.

We are looking for a QA Professional who will be an expert in our Quality Management System and in our corporate Product Lifecycle Management system (Agile) - and collaborate closely with colleagues in Malaysia, China and USA as well as with colleagues in Denmark.

You will work from our Headquarters in Ballerup, and join a QA/RA team of approximately 15 colleagues in Denmark and you will refer to the Director of Corporate QA Systems.

In your new position, you will be a driver of continuous improvements and efficient processes and you will take an active role in building up the tools and methods we use in our daily work. You will be part of an effective quality culture, where we keep ahead of new regulatory requirements and constantly strive for improvements. This sets high demands to your project management skills, experience as well as quality and business understanding.

A global job with impact
As QA Professional, you will get a varied working day in a dynamic organisation where you get to influence Ambu’s processes as well as your own daily tasks and responsibilities. Your key responsibilities will be to:

  • Drive projects to develop our Quality Management System and ensure and maintain efficient and lean procedures
  • Maintain, develop and improve our global processes and structures in the Product Lifecycle system (Agile) for change control and document control
  • Train super users worldwide in these processes and structures
  • Act as Change Analyst to ensure that design changes are processed according to procedures and are reviewed and approved according to regulatory and Ambu requirements
  • Act as quality system auditor
  • Manage the QA role in IT projects - including review of software validation documentation (including 21 CFR Part 11)
  • Complete assignments related to Quality Management System integration and partnership projects

Experience with Medical Devices and Quality Assurance
To succeed in the job, you need to have a background as engineer or similar and 2-5 years experience with quality assurance in the medical device or pharmaceutical industry. In addition, you have experience with writing procedures and SOP’s and a flair for working with IT systems.

It will be an advantage if you have knowledge of ISO 13485, 21 CFR Part 820, audit and software validation, and if you have a business and process understanding.

It is important that you have great cooperation skills and a structured approach to your work. At the same time, you are open-minded and see possibilities even when daily life is dynamic and hectic.

You are able to work independently, but you also like to work in teams by being a team player. It is natural for you to be analytical, take charge, and be good at prioritising, planning and finalising your tasks as well as being proactive.

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.

Information 
You can get more information about the job and about Ambu A/S by contacting Director, Corporate QA Systems, Annette Jonassen, telephone no. +45 7225 2000 or by e-mail annj@ambu.com.

How to apply
If you are interested in applying for the position, then please apply as soon as possible and no later than March 5th, 2017. 

Your application will be treated as confidential.

Please write in your application that you've seen the job at Jobfinder