Senior Quality System Engineer - Corporate QA Systems

Are you passionate about quality? Do you like to work with Quality Management System compliance and continuous improvement of processes? Do you have experience with internal audits, managing inspections by authorities and heading up projects in a Quality organization?  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 develops, manufactures and sells 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 Senior Quality System Engineer who can take up this exiting position in the Corporate QA Systems department. As a Senior Quality Systems Engineer you will take an active role in driving projects within the QA organization, facilitating understanding of quality requirements across the Ambu organization, driving continuous improvement of global processes and collaborating closely with colleagues in Denmark, Malaysia, China, USA and Germany.

You will be part of a strong quality culture, where we keep ahead of new regulatory requirements and constantly strive for improvements. This sets high demands to your experience, project management skills, as well as quality and business understanding. You will work from our Headquarters in Ballerup, Denmark and join a QA Systems team of 6 colleagues where you will refer to the Director of Corporate QA Systems.

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

Your key responsibilities will be to:

• Act as QA project manager and drive projects related to Ambu integrations & partnerships as well as projects to continuously develop the Quality Management System
• Maintain, develop and improve global QMS processes
• Drive and participate in global quality fora to discuss proactive process improvement
• Build strong partnerships with Ambu business areas, supporting process owners in understanding the quality requirements for their processes
• Perform internal audits and corporate audits of other Ambu sites
• Manage and participate in inspections by authorities and related follow up
• Perform training in general quality requirements and/or specific quality processes 

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 6-10 years’ experience from working within a quality organization for Medical Devices.

It is considered an advantage if you have experience from working in different areas of a quality organization.

You have extensive knowledge of Quality Management System requirements for Medical Devices such as ISO 13485, EU MDR, 21 CFR Part 820. Knowledge of MDSAP requirements is an advantage.

In addition, you have demonstrated experience as an internal auditor, as well as experience with driving and participating in projects within a Quality organization.

As a person, you have a good business understanding and are confident in communicating quality requirements and facilitating effective implementation in an organization. You are a strong communicator, focusing on respectful dialogue with your colleagues. It is important that you have a strong drive, take lead of different quality initiatives, and that you can work independently. You take pride in good collaboration, and you are open-minded and see possibilities even when daily life is dynamic and hectic. 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 6th June, 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 3,100 people in Europe, North America and the Asia Pacific. For more information, please visit www.ambu.com

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