Quality Assurance Engineer in Device Research & Development
Are you ready to use your quality mindset to ensure patient safety and compliance in our device development projects? Can you interpret regulations and standards for mechanical and connected devices and find the best way of implementing quality in our diverse portfolio of development projects?
In this job you work directly with the project teams on developing superior devices that improves the lives of our users all over the world.
About the department:
We are a team of 15 passionate Quality Assurance experts with diverse backgrounds and based in Hillerød.
Along with the rest of Device R&D we have a high focus on patients and take pride in having a significant impact on the life of patients by ensuring high quality, safe, and effective products.
In Novo Nordisk we strive for simplicity and never compromise on Quality. The key challenge for a Quality Assurance engineer is to make the two go hand in hand.
As a Quality Assurance Engineer, you will be responsible for supporting our development projects with setting direction in terms of internal and external requirements. This is achieved by reviewing and approving design control documents, but also through participation in project discussions where you will act as a representative for Device R&D QA. Your ability to find the best way of achieving both quality and other project objectives, and set a clear direction is therefore a key responsibility as a Quality Assurance Engineer.
You are a part of the development process from early innovation until launch, give input to project planning, and ensure project deliverables at each development phase. You work with many different stakeholders both internally in Novo Nordisk, but also with outsourced development partners in which case you ensure Quality oversight of our international partners.
Additionally, you take part in the development of our Quality Management System (QMS) and drive QMS improvement activities in Device R&D. Finally, you provide support during authority inspections and internal audits, both in the practical setup and in presenting documentation.
You hold an engineering, science, or other relevant academic degree and have a strong quality mindset. Experience within design, test, or Quality Assurance of mechanical and electronic devices is an advantage, as is experience from other regulated industries e.g. pharmaceutical, aerospace/automotive, or oil/gas.
You are great at constructively engaging your stakeholders. You quickly understand situations and dilemmas and are solution oriented in supporting innovation within procedural and regulatory constraints. You are good at translating regulatory guidance into operational practice to support Device R&D. You communicate clearly and use facts to present your point of view when needed to ensure regulatory compliance or patient safety.
You spot when our processes can be improved and have the drive to make change happen. You are fluent in both written and spoken English on a professional level.
Working at Novo Nordisk:
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.
For further information, please call Mikkel Avlund at +45 3075 7095.
14th of November, 2019.
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