QA Engineer for Software as a Medical Device in Device Research&Development
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Hillerød
- Quality
- Hillerød
Do you want to take part in getting high quality digital health products into the hands of our users? Do you have what it takes to ensure that regulatory compliance and patient safety is in place? In this job you work directly with the project teams on the development of apps and software algorithms to improve the lives of diabetes patients.
About the department
Device R&D has a long and outstanding track record of developing the best, most innovative and widely used injection devices in the world. The next leap for these devices is to become connected enabling Novo Nordisk to support our users even better through digital health solutions. In our quality department we are responsible for supporting project documentation, authority inspections, Quality Management System (QMS) and training. We support projects developing mechanical and connected medical devices, as well as Software as a Medical Device (SaMD).
We are a team of 15 passionate QA experts with diverse background and based in Hillerød. In Novo Nordisk we strive for simplicity and never compromise on Quality and the challenge for QA is to make the two go hand in hand. In our team we work together to meet peak demands and balance the workload on a weekly basis.
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.
The Position
As a QA engineer for Software as a Medical Device, you will be responsible for supporting our projects within digital health, primarily through providing guidance and reviewing/approving design control documents. You will work cross-organisationally, supporting projects in Device R&D and Digital Health in Denmark, as well as projects in Device R&D in Seattle, USA, and with our international partners responsible for programming and testing. You will participate in the development process from early innovation until commercialisation of the software.
You keep yourself up to date and identify relevant external requirements for Software as a Medical Device, in order to ensure and develop our quality and compliance. In the process, you collaborate with different stakeholders and actively set direction for our QA work in SaMD.
You ensure that activities in your areas are in compliance with the Novo Nordisk Quality Management System (QMS). To support this, you train and guide colleagues in the right use of QMS. Additionally, you take part in the development of QMS and drive QMS improvement activities. Finally, you provide support during authority inspections and internal audits, both in the practical setup and in presenting documentation.
Qualifications
You hold an IT, Engineering, or other relevant academic degree and a strong quality mindset. Experience within software development and IT security is an advantage, as is experience from a regulated industry e.g. pharmaceutical, aerospace/automotive, or oil/gas.
You are great at constructively engaging your stakeholders. You quickly understand situations and dilemmas and are creative in finding solutions supporting innovation within procedural and regulatory constraints. You are good at translating regulatory guidance into operational practice. You communicate clearly and use facts to present your point of view when needed to ensure regulatory compliance and patient safety.
You have the ability to spot when our processes can be improved, as well as 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.
Contact
For further information, please call Mikkel Avlund at +45 3075 7095.
Deadline
14 August 2019.
Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.
Information og data
Denne ledige stilling har jobtypen "Softwareudvikler", og befinder sig i kategorien "Informationsteknologi".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 17.7.2019, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Softwareudvikler
- Hillerød
- Onsdag den 14. august 2019
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