Quality Assurance Professional
- Quality
- Denmark - Hillerød
Do you have a mind for quality assurance? Can you guarantee the quality of newly developed health care devices? Then join Novo Nordisk’s Device Manufacturing Development (DMD) as our new Quality Assurance Professional and contribute to defeating diabetes worldwide
About the department
You will be part of a team of 13 dedicated colleagues, in Hilleroed. Together, we are responsible for assuring the quality of Medical Devices developed by our R&D department every step of the way from the development processes to pilot production. We also assist the transfer into high volume production that takes the finished product to markets worldwide
The job
You will, as a delegated Qualified Person be responsible for status assignment of final assembled combination products for clinical trial. On an operational level, you ensure that the devices are assembled in full alignment with the given regulations. You review the requests for changes, e.g. of the production equipment, and review the cases of non-conformities in the production. You also provide quality support to the process responsible persons and R&D departments’ device projects. You have experience with risk based approach validation of assembly processes. From a LEAN perspective you point to processes and procedures that can be optimised without compromising the quality. Supporting the ideas for optimisation you approve the necessary documentation accordingly. Monitoring trends across processes are also one of your main objectives and your curiosity and thoroughness helps the organisation to identify issues for improvement.
You can look forward to entering into an energetic and positive working environment where cooperation is a keyword.
Qualifications
Your approach to this position is a relevant degree as a Pharmacist. On top of that, you have 3-5 years’ experience which has provided you with solid knowledge of requirements such as ISO 13485, CFR 21 Part 820 and GMP. To be successful in this position you must possess experience with LEAN that allows you to suggest ways to make processes more efficient. Moreover, you have a high level of fluency in written and spoken English.
On a personal level, you are known for dedicating yourself to working proactively to solve the task at hand. Using your ability to think outside the box, you are still able to come up with solutions or suggestions that comply with quality requirements. In addition, you are able to handle complex tasks and deliver in due time to meet our customers’ expectations. You are a team player and a skilled communicator, and you thrive on unfolding your high level of energy and spirit in an international, dynamic environment.
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 ProductSupply 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 Dean Kloe at +45 3075 8948.
Deadline
10 August 2013.
- Quality
- Denmark - Hillerød
Do you have a mind for quality assurance? Can you guarantee the quality of newly developed health care devices? Then join Novo Nordisk’s Device Manufacturing Development (DMD) as our new Quality Assurance Professional and contribute to defeating diabetes worldwide
About the department
You will be part of a team of 13 dedicated colleagues, in Hilleroed. Together, we are responsible for assuring the quality of Medical Devices developed by our R&D department every step of the way from the development processes to pilot production. We also assist the transfer into high volume production that takes the finished product to markets worldwide
The job
You will, as a delegated Qualified Person be responsible for status assignment of final assembled combination products for clinical trial. On an operational level, you ensure that the devices are assembled in full alignment with the given regulations. You review the requests for changes, e.g. of the production equipment, and review the cases of non-conformities in the production. You also provide quality support to the process responsible persons and R&D departments’ device projects. You have experience with risk based approach validation of assembly processes. From a LEAN perspective you point to processes and procedures that can be optimised without compromising the quality. Supporting the ideas for optimisation you approve the necessary documentation accordingly. Monitoring trends across processes are also one of your main objectives and your curiosity and thoroughness helps the organisation to identify issues for improvement.
You can look forward to entering into an energetic and positive working environment where cooperation is a keyword.
Qualifications
Your approach to this position is a relevant degree as a Pharmacist. On top of that, you have 3-5 years’ experience which has provided you with solid knowledge of requirements such as ISO 13485, CFR 21 Part 820 and GMP. To be successful in this position you must possess experience with LEAN that allows you to suggest ways to make processes more efficient. Moreover, you have a high level of fluency in written and spoken English.
On a personal level, you are known for dedicating yourself to working proactively to solve the task at hand. Using your ability to think outside the box, you are still able to come up with solutions or suggestions that comply with quality requirements. In addition, you are able to handle complex tasks and deliver in due time to meet our customers’ expectations. You are a team player and a skilled communicator, and you thrive on unfolding your high level of energy and spirit in an international, dynamic environment.
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 ProductSupply 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 Dean Kloe at +45 3075 8948.
Deadline
10 August 2013.