Development Quality Engineer
- Quality
- Denmark - Hillerød
Are you ready to make a difference and proactively influence the future device development projects in Novo Nordisk? As Development Quality Engineer in Device Manufacturing Development (DMD) you will use your quality-focused mindset to make a serious difference and contribute to defeating diabetes worldwide.
About the department
You will be part of a team of 13 dedicated colleagues, including 10 QA Engineers, in Hillerød. Together, we are responsible for assuring the quality of devices developed by our development departments, processes to pilot production and transfer processes into high volume production that takes the finished product to markets worldwide.
The job
Your main objective is to be quality responsible in device development projects – devices for diabetic treatment. The devices to be developed are durable devices which include electronics. Your main focus will be on the electronic development tasks. Your quality tasks are to secure the development is done according to the written design control procedures, e.g. review and approve design inputs such as product requirements, component specifications for metal, plastic and electronics, product risk analyses and implementation of mitigations, review/approve engineering change orders and later in the development process you will prepare control specifications for in-coming and out-going inspection. Furthermore you must cover supplier evaluation and assure new suppliers are evaluated according to the quality requirements they are intended to be used for. The development departments will need your support in preparing development agreements if development is done at a supplier. It is your responsibility to secure that the design inputs still are prepared according to regulatory and quality requirements. Anticipate visits to suppliers in Europe and Asia between 10–30 days a year.
Qualifications
Your approach to this position is a relevant engineering degree (B.Sc. or M.Sc. level) within Electronics, Mechanics, Manufacturing or Medicine and Technology. You have knowledge with the requirements ISO 13485, 21 CFR Part 820 and ISO 14971. You have worked with development projects, supplier tasks in general, you know how to fulfil the regulatory and quality requirement when cooperating with suppliers that develop devices together with the development departments and you are familiar with an international environment.
On a personal level, you are known for dedicating yourself to working proactively to solve the tasks at hand and you are talented within coordination of tasks.Your ability to convince your colleagues to follow written procedures is excellent and you like to present the essence of the quality importance for those where you see a need. You are aware that convincing and presenting often is successful when you have prepared solid facts and data. Moreover, you have a high level of fluency in written and spoken English.
In Novo Nordisk it is your skills, your commitment and your ambitions, which helps us to improve many people's lives. In return we offer you the opportunity to work with exceptionally talented colleagues, and we offer you a wide range of opportunities for professional and personal development.
Learn more about Novo Nordisk Product Supply and working in QA using this link www.novonordisk.com/careers/QA
Feel free to submit your job application in either English or Danish, whichever you prefer.
Contact
For further information, please contact Malene Fugl Andersen at + 45 3075 8982.
Deadline
9 September 2013.
- Quality
- Denmark - Hillerød
Are you ready to make a difference and proactively influence the future device development projects in Novo Nordisk? As Development Quality Engineer in Device Manufacturing Development (DMD) you will use your quality-focused mindset to make a serious difference and contribute to defeating diabetes worldwide.
About the department
You will be part of a team of 13 dedicated colleagues, including 10 QA Engineers, in Hillerød. Together, we are responsible for assuring the quality of devices developed by our development departments, processes to pilot production and transfer processes into high volume production that takes the finished product to markets worldwide.
The job
Your main objective is to be quality responsible in device development projects – devices for diabetic treatment. The devices to be developed are durable devices which include electronics. Your main focus will be on the electronic development tasks. Your quality tasks are to secure the development is done according to the written design control procedures, e.g. review and approve design inputs such as product requirements, component specifications for metal, plastic and electronics, product risk analyses and implementation of mitigations, review/approve engineering change orders and later in the development process you will prepare control specifications for in-coming and out-going inspection. Furthermore you must cover supplier evaluation and assure new suppliers are evaluated according to the quality requirements they are intended to be used for. The development departments will need your support in preparing development agreements if development is done at a supplier. It is your responsibility to secure that the design inputs still are prepared according to regulatory and quality requirements. Anticipate visits to suppliers in Europe and Asia between 10–30 days a year.
Qualifications
Your approach to this position is a relevant engineering degree (B.Sc. or M.Sc. level) within Electronics, Mechanics, Manufacturing or Medicine and Technology. You have knowledge with the requirements ISO 13485, 21 CFR Part 820 and ISO 14971. You have worked with development projects, supplier tasks in general, you know how to fulfil the regulatory and quality requirement when cooperating with suppliers that develop devices together with the development departments and you are familiar with an international environment.
On a personal level, you are known for dedicating yourself to working proactively to solve the tasks at hand and you are talented within coordination of tasks.Your ability to convince your colleagues to follow written procedures is excellent and you like to present the essence of the quality importance for those where you see a need. You are aware that convincing and presenting often is successful when you have prepared solid facts and data. Moreover, you have a high level of fluency in written and spoken English.
In Novo Nordisk it is your skills, your commitment and your ambitions, which helps us to improve many people's lives. In return we offer you the opportunity to work with exceptionally talented colleagues, and we offer you a wide range of opportunities for professional and personal development.
Learn more about Novo Nordisk Product Supply and working in QA using this link www.novonordisk.com/careers/QA
Feel free to submit your job application in either English or Danish, whichever you prefer.
Contact
For further information, please contact Malene Fugl Andersen at + 45 3075 8982.
Deadline
9 September 2013.