Device Quality Specialist

Do you want to improve quality processes in a global context?

LEO Pharma has set out to become the world’s leading dermatology care partner. Part of fulfilling this very ambitious goal is founded on our ability to take our medical device operation to the next level. And that is why we need you. If you bring quality system expertise within medical devices and you are looking for an opportunity to unfold all of your skills in a wider context, this exciting job is just what you want. You can look forward to a job with plenty of opportunities for impact and influence in an open and welcoming environment manned with skilled and helpful colleagues.

Medical device QMS expert and driver of cross-organisational quality processes

You will become key driver of anchoring all medical device related requirements in our global QMS. At the same time you will handle other quality tasks in order to create and implement smart and business focused global processes – to ensure your development and to benefit from your knowledge. We expect a 70/30 split between device related and more general improvement initiatives. Your primary tasks will be to:

  • Ensure compliance with ISO13485, FDA CFR 21 part 820 and other legislation as applicable
  • Drive and support implementation of actions related to changes in regulatory requirements for medical device
  • Contact and collaboration with the Notified Body
  • Drive and support continuous improvement of the QMS especially regarding medical devices
  • Support the department in driving a process-oriented approach to standardisation and optimisation across LEO Pharma

Extensive knowledge of relevant legislation and requirements for medical devices

You have a degree at Master’s level and at least 6-7 years’ experience from working hands-on with Quality Assurance of medical devices. Ideally, you have some experience from working with cross-organisational processes based on lean principles. Regardless of your background you must bring extensive knowledge of relevant legislation and requirements for Quality Management Systems for medical devices including:

  • Medical Device Directive 93/42/EC
  • Medical Device Regulation (EU) 2017/745
  • ISO13485
  • 21 CFR Part 4, Part 11 and 820
  • ISO 14971 and other legislation as applicable  

As Quality Specialist you have a natural attention to details and the ability to think systematically as well as applying logical and smart systems to your work. Equally important is your pragmatic attitude towards creating results via collaboration. You thrive on taking the lead and you can do it in way that makes people follow your agenda because they can see you understand and respect their specific situation and business objectives.

Your new team

You will join a small and agile team of 6 Quality Professionals in Quality Systems and Processes based at the LEO Pharma headquarters in Ballerup, Greater Copenhagen. Our responsibility covers development and maintenance of LEO’s global QMS, optimisation of quality processes, handling of customer complaints, capturing and anchoring of new and revised GxP requirements as well as providing LEO with data and metrics on quality performance. Across our tasks and objectives we have a clear cut ambition to add value by being the organisation’s partner to achieve effective compliance with quality processes.

We look forward to receiving your application.

» Apply for job
About LEO Pharma
LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions.
Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions.
LEO Pharma is headquartered in Denmark and employs around 5,300 people worldwide.
For more information, visit www.leo-pharma.com.
Application deadline: 31/05/2018

Location: Ballerup, Copenhagen

Job type: Permanent

Working hours: Full-time

Contacts: Sofie Dombernowsky
Telephone: +45 3122 2450