Quality System Engineer

Indrykket: 27.8.2020

Ballerup

Quality System Engineer – Corporate QA Systems

Join us in shaping the future of Ambu Medical Devices

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

We are looking for a Quality System Engineer, who can take up this exiting position in the Corporate QA Systems department. You will work within the department focus area “Agile & Computerized Systems Compliance”.

As Quality Systems engineer you will have multiple QA responsibilities related to the company’s global Product Lifecycle Management System (Agile), perform QA review of document-, part- and IT Changes and participate as QA representative in a long and ambitious pipeline of Corporate IT projects for new and existing global IT systems in Ambu.

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:

  • Maintain and continuously improve QMS processes within Corporate QA Systems area of responsibility, including improvements of processes in Ambu’s Agile PLM System.
  • Act as change analyst for changes to Quality Management System documents and parts.
  • Be the main responsible for coordinating and conducting basic document and change control training of new Agile PLM users. Develop e-learnings supporting this.
  • 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.

Experience and passion
To succeed in the job, you must have a relevant academic background - e.g. a MSc / BSc in engineering or similar, as well as 1-3 years’ experience from working within a Quality Assurance department for Medical Devices or Pharmaceuticals.

You have;

  • Experience with QA activities related to Document Management and Change Control.
  • Flair for working in IT Systems
  • Experience with, or interest in, driving and performing training activities.
  • Experience with, or interest in computerized system compliance and IT validation.
  • 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 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.

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 Sept. 20, 2020, 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.

About Ambu
Since 1937, breakthrough ideas have fuelled our work on bringing efficient healthcare solutions to life. This is what we create within our fields of excellence – Anaesthesia, Patient Monitoring & Diagnostics, and Emergency Care. Millions of patients and healthcare professionals worldwide depend on the functionality and performance of our products. We are dedicated to improve patient safety and determined to advance single-use devices. The manifestations of our efforts range from early inventions like the Ambu Bag™ resuscitator and the legendary BlueSensor™ electrodes to our newest landmark solutions like the Ambu aScope™ – the world’s first single-use flexible endoscope. Our commitment to bringing new ideas and superior service to our customers has made Ambu one of the most recognized medical companies in the world. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,200 people in Europe, North America and the Asia Pacific. For more information, please visit www.Ambu.com