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QA Engineer (Hillerød, Denmark)

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QA Engineer

- Quality
- Denmark - Hillerød

Do you like to work in an international environment where you play a central part of the communication with the supply chain for the production of medical devices regarding complaint handling? Are you motivated by working in a team with many stakeholders where you play a central role of the root cause investigations, coaching and challenging our suppliers on a daily basis?

About the department
Our department comprises 20 highly qualified QA engineers QA supporters. The QA supporters are responsible for the handling and communication of the complaints for all Novo Nordisk prefilled devices that comes from our customers. They review and challenge root cause investigation documentation and drive a continuous development of this competence at the suppliers.

They participate and drive the weekly customer and supplier meetings (in general video conference). Another task is to perform component reviews at the supplier together with the QA supplier responsible. This task involves review of IPC component samples, batch documentation and other related GMP documentation to verify that the supplier is in compliance.

The job
In QA External Manufacturing & Sourcing we are looking for a structured and dedicated person with preferably academic background (technical/engineering/pharma) who will be a part of a team of 6 QA supporters handling among all Internal Complaints (IC) and Non-conformities (NC) from our customers.

Your job area will be within the fields of advanced injection moulding and springs for medical devices. Our suppliers are located in Scandinavia, Europe, USA and Brazil.

With support from your colleagues and in close dialogue with QA, PTA, DMD and R&D you will independently handle complaints from when they are received in DMS to when the complaints are concluded by QA. This process is generally done in a close cooperation with our suppliers.

We expect you to have a yearly travel frequency of about 30-40 days.

We offer you a position in an international company with many exiting challenges giving you a possibility for individual development. We prioritise a good work life balance. We are located in Hillerød in nice surroundings and new facilities approx. 30 km. north of Copenhagen.

Qualifications
You are goal-oriented, known for being organised and take responsibility for your tasks. You are motivated by solving complex tasks by constructive communication based on your knowledge and understanding of quality without compromising patient safety. You have at least 2-3 years of professional experience within industry. If you have worked with metal and spring processes or injection moulding as well as suppliers in a global environment it is an advantage. The ideal candidate has experience in ISO13485, cGMP and Lean. You master English on an intermediate communication level.

On a personal level you are ambitious and have a great interest in developing yourself. You make a difference and by your dedicated and determined approach you complete your tasks in close cooperation with your colleagues. You are independent and not afraid to take initiatives. You have a good sense of humour.

At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.

Contact
For further information, please contact Charlotta Schönbeck on +45 3075 8404.

Deadline
7 September 2013.

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