Quality Professional with knowledge about Design Control
Novo Nordisk A/S
Hillerød, 1 stilling
- Denmark - Hillerød
Would you like to help securing Novo Nordisk portfolio of devices continuously are maintained to the benefit of our customers? Do you get energised by working in a team, handle multiple tasks on a daily basis in a global environment? Then you might be the person we are looking for in Device Manufacturing Development (DMD) QA.
About the department
DMD is dedicated to be the best manufacturing development partner in the field of medical devices. Our dedication, as a QA organisation, is to get superior quality built into our processes to ensure excellent quality of our finished devices. In DMD Product Maintenance QA we are responsible for securing the specified quality of our devices and combination products at all levels.
You will contribute by ensuring the right product quality through activities related to Product Maintenance. You will drive the quality assurance activities in relation to maintaining the documentation of all our marketed devices and combination products. More concrete - you will drive the QA reviewer tasks on technical customer complaint investigations, change requests, risk management, approval of specifications etc.
You will be QA responsible for approving quality specifications, design history file documentation, risk management documentation at the right level that will ensure high quality products fulfilling all regulatory requirements.
In your daily work, you will interact with several departments internally and externally and your success will depend on your ability to be a role model with regards to collaboration and communication with all types of colleagues and business partners while keeping the quality of the products in mind.
The position offers you a unique opportunity to leave your mark while realising your goals and seeing the benefits of your work. Overall, you will have a great degree of freedom in the job, working where you can plan your own day-to-day work. Travel activities can occur.
You hold a relevant academic degree in engineering (preferable mechanics), pharmacy or equivalent with 3-5 years of experience within quality assurance and/or device industry.
You have an excellent quality mind-set, good communicational skills and you can place the importance of product quality, patient safety and compliance on the agenda in a positive and constructive way.
Your language skills cover proficiency in English, and it is a must that you have knowledge within the requirements of ISO 13485, 21 CFR Part 820, 21 CFR Part 4 and ISO 14971 especially Design Control and Risk Management.
As a person, you are known for a high commitment as well as taking responsibility for your assignments. You work independently and make decisions regarding quality tasks and at the same time, you perform well in a team-oriented environment.
Working at Novo Nordisk
At Novo Nordisk, we strive for excellence. As a world leader in diabetes care and a major player in haemostasis management, growth hormone, hormone replacement therapy, we offer our employees opportunities for continuous growth.
For further information, please contact Anja Stranum Monger on + 45 3075 7049.
1 June 2016.