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Quality System Consultant, Medical Device (Maternity Cover)

  • GN
  • 2750 Ballerup, Danmark
  • 23/06/2022

Jobbeskrivelse

GN is a global leader in intelligent audio solutions that let you hear more, do more and be more than you ever thought possible. The surveillance of and continuous work on the quality of our products is vital. Our new colleague is going to play an important role in managing our Quality Systems by helping and guiding colleagues globally.

Welcome to our Quality Systems team

We are 7 team members in Quality Systems and part of Corporate Quality (CQ) in headquarter.

CQ is responsible for regulatory compliance, market access, post market surveillance, quality systems, improvements, and processes.

Quality systems is responsible for driving the global quality system, as well as developing and supporting our worldwide sites in their quality system related issues and processes. Furthermore, we are managing the global CAPA (Corrective and preventive actions) system and quality planning in headquarter. Finally, we are Business leads on our IT Business tools that supports the quality systems, electronic document approval, training, CAPA´s, non-conformances and audits.

As part of CQ in Headquarter, we also have the privilege of learning and affecting the process of developing our products, manufacturing them and how they perform in the market (Post Market Surveillance and Customer Satisfaction).

What you will be doing:

During this fixed term employment you will develop your stakeholder talents and collaboration skills, your generic IT understanding and your business insight together with supervisors, superusers and Internal IT/External IT. You will be the main contact /anchor on the business side, supported by the Business owner (Head of Quality systems).

You will act as the temp for our Quality Systems Business Lead. To give you a feel for the global nature of the job, interactions will range from R&D colleagues in headquarters in Denmark, sales site system setup in Singapore and Brazil, custom production set-up and regulatory system registration in US to major scale production in Malaysia and China to mention a few.

We do not expect you to be familiar with all our systems, but expect you will develop into someone who can contribute with:

  • Consultant on our IT QMS solutions for the general Quality system, CAPA´s / Non-Conformances /Audit´s, electronic document approval and training (Smartsolve, Sharepoint- and Microsoft platforms)
  • Contributor to our global quality management system suite
  • Global Quality Performance measurement (KPI) responsible
  • Representative from Quality Systems in audits
  • Supporter of the general operation of the local and global quality management system

Part of your role reporting on KPI’s will require you to follow-up and ensure that our different stakeholders report on different Quality KPI’s. It is your responsibility to gather data, make overall simple assessments and share the results with the CQ Management group.

Finally, due to the nature of our area, you will participate in our operational activities like audits and general support.

Your possible background and qualifications

We imagine that there can be several ways of contributing meaningfully to this role. Overall, we expect you to be interested in Quality, IT Systems and cooperation with many different people across borders and cultures. Formally, we expect that the following will increase your chances of success:
 

  • Experience from working with quality in a regulated international company
  • Good IT and System understanding
  • Generic business understanding
  • ISO 9001 or 13485 system- experience

We focus on attitude, proactive behavior and potential, not loads of experience. We will train you if necessary. The right key profile will experience lots of possibilities for development.

What we offer

Our dynamic workplace offers plenty of different benefits and flexibility to keep us happy and healthy and allow us to focus on what matters to us in and outside of work.

We hope you are curious to explore and engage in the recruitment process with us.

How to apply

To apply, use the ‘APPLY’ link no later than 7 July 2022. 

If you want to know more about the position, you are welcome to connect with hiring manager, Head of Quality Systems Kim Glenert on LinkedIn: https://www.linkedin.com/in/kim-glenert-1ba0011/

We look forward to hearing from you.

#LI-ReSound