Quality Systems Engineer
- Production
- Denmark - Hillerød
Are you ready to realise your potential? As Quality Systems Engineer you will carry a great responsibility in our striving towards strengthening Novo Nordisk’s position as an innovative pioneer and respected industry leader.
About the department
You will be part of Durable Device Product Maintenance in Hillerød. Here, you will have 15 extremely dedicated and motivated colleagues - counting Technical Engineers, Quality Systems Engineers and Projects Managers - working in close dialogue with our production site in China. We have a very important role maintaining the design and manufacturing processes of Novo Nordisk’s prize-winning durable injection pens. Together, we change lives.
The Job
You will be responsible for the improvement and standardisation of our processes for product maintenance. Moreover, you make sure that the product documentation base – i.e. technical files, validation documentation, etc. – is, at all times, in compliance with requirements of Novo Nordisk and the authorities. You design, implement and improve the standardised documentation processes, and as we have short lines of decision-making, you will, to a large extent, have a say in the chosen solutions. Configuration management and risk management will be key words in your daily assignments, and you will perform effective CAPA investigations to prevent failures. To secure approval of the products you maintain device master records, and you always bear in mind that the products and processes are in regulatory compliance with the current standards. You will have a wide range of stakeholders in Novo Nordisk across portfolio, products and departments.
Qualifications
You have extensive experience from a comparable position – at least 10 years – topped with a degree in one of the natural sciences. This background has given you a broad and comprehensive insight into product maintenance. You have acquired in-depth know-how on the use of product maintenance systems, and you are confident applying the continuous improvement methodology, process validation as well as performing product and process risk management. In addition, you are familiar with IT systems for product documentation and used to diving into statistical data in your daily work. Your optimisation projects will change the flow of work for your colleagues, and you know how to secure buy-in using positive and explanatory means of communication. And you thrive in a position where you pull the strings as the interface between many stakeholders. Lastly, you are characterised as a systematic, meticulous and analytic profile, and you know your turf, which allows you to stand firm on your solutions.
At Novo Nordisk, decisions and actions are based on their positive impact on society, the environment and on their potential to generate a profit. That makes for a responsible culture with a healthy and engaging working environment.
Contact
For further information, please contact Hannibal Brennum at +45 3075 9840.
Deadline
12 January 2014
- Production
- Denmark - Hillerød
Are you ready to realise your potential? As Quality Systems Engineer you will carry a great responsibility in our striving towards strengthening Novo Nordisk’s position as an innovative pioneer and respected industry leader.
About the department
You will be part of Durable Device Product Maintenance in Hillerød. Here, you will have 15 extremely dedicated and motivated colleagues - counting Technical Engineers, Quality Systems Engineers and Projects Managers - working in close dialogue with our production site in China. We have a very important role maintaining the design and manufacturing processes of Novo Nordisk’s prize-winning durable injection pens. Together, we change lives.
The Job
You will be responsible for the improvement and standardisation of our processes for product maintenance. Moreover, you make sure that the product documentation base – i.e. technical files, validation documentation, etc. – is, at all times, in compliance with requirements of Novo Nordisk and the authorities. You design, implement and improve the standardised documentation processes, and as we have short lines of decision-making, you will, to a large extent, have a say in the chosen solutions. Configuration management and risk management will be key words in your daily assignments, and you will perform effective CAPA investigations to prevent failures. To secure approval of the products you maintain device master records, and you always bear in mind that the products and processes are in regulatory compliance with the current standards. You will have a wide range of stakeholders in Novo Nordisk across portfolio, products and departments.
Qualifications
You have extensive experience from a comparable position – at least 10 years – topped with a degree in one of the natural sciences. This background has given you a broad and comprehensive insight into product maintenance. You have acquired in-depth know-how on the use of product maintenance systems, and you are confident applying the continuous improvement methodology, process validation as well as performing product and process risk management. In addition, you are familiar with IT systems for product documentation and used to diving into statistical data in your daily work. Your optimisation projects will change the flow of work for your colleagues, and you know how to secure buy-in using positive and explanatory means of communication. And you thrive in a position where you pull the strings as the interface between many stakeholders. Lastly, you are characterised as a systematic, meticulous and analytic profile, and you know your turf, which allows you to stand firm on your solutions.
At Novo Nordisk, decisions and actions are based on their positive impact on society, the environment and on their potential to generate a profit. That makes for a responsible culture with a healthy and engaging working environment.
Contact
For further information, please contact Hannibal Brennum at +45 3075 9840.
Deadline
12 January 2014