Quality Assurance Engineer - drug device interface
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Hillerød
- Engineering
- Hillerød
Quality Assurance Engineer - drug device interface
Do you have the experience to set direction for the drug device interface quality in our new device paradigms? Can you interpret regulations and standards and find the best way of implementing quality in close collaboration with our device development projects?
In this job you support our portfolio of exciting new drug delivery device projects, as well as creating new variants of existing platforms – all with a direct impact on improving the lives of our users all over the world.
About the department
Device R&D Quality is responsible for covering all quality aspects in the Device R&D portfolio of mechanical devices, devices with embedded electronics and software, and Software as a Medical Device, as well as projects investigating new paradigms for drug delivery. Further, we support Quality Management System activities, quality oversight of our suppliers, and host inspections.
We are an international team of 16 passionate Quality Assurance experts with diverse backgrounds of which the vast majority is based in Hillerød, Denmark – and a small part in the Device R&D satellite in Seattle, USA.
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
In this position, your will provide support to various projects in our Device R&D portfolio and in particular focus on some of our exciting next generation devices, which transcend the state-of-the-art pen injection systems. These new projects tend to have an intricate interface between drug and device, they may involve alternative delivery technologies and will typically be classified as class IIB or III.
As a Quality Assurance Engineer, you will be responsible for supporting our development projects with setting direction for quality in terms of internal and external requirements. This is achieved both proactively by supporting the projects in making the right approach to quality, and by reviewing and approving design control documents. Your ability to find the best way of achieving both quality and other project objectives, and set a clear direction is 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 supporting the projects in presenting documentation.
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.
Qualifications
You hold a pharmaceutical, scientific (e.g. microbiology or biochemistry), engineering or other relevant academic degree and have a strong quality mindset. You have at least 4 years of experience as a QA in a medical context.
You have worked within drug development and Good Laboratory Practice, within development of primary packaging, or within device development and Good Manufacturing Practice (i.e. 21 CFR 820, MDD, MDR, ISO 13485, and ISO 14971). Experience with class III devices is an advantage, as is experience with combination products where the interface between drug and device is more intricate than in a regular pen dosing system.
Some of your strengths are to constructively engage your stakeholders and navigate in cross organisational stakeholder landscapes. And that 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, and at finding the relevant regulatory requirements, when a development project is on unknown ground. You communicate clearly and use facts to present your point of view when needed to ensure regulatory compliance or patient safety.
In addition, 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.
Contact
For further information, please call Mikkel Avlund at +45 3075 7095.
Deadline
August 20, 2020.
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 "Produktchef", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Hillerød.
Jobbet er oprettet på vores service den 30.4.2020, 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.
- Produktchef
- Hillerød
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