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Quality Assurance Engineer, Development of Medical Devices

Category:  Quality
Location: 

Hillerød, Capital Region of Denmark, DK

   

Are you a solution-oriented person with a passion for Quality Assurance? Do you get motivated by working in project teams, to ensure high quality products in complex device development? Are you inspired by following regulatory requirements and use quality as an active driver of device development projects? If yes, then you might be the person we are looking for in Devices & Delivery Solutions Quality in Hillerød.

 

About the Department:

Devices & Delivery Solutions Quality is part of R&D Quality and is accountable for covering all quality aspects in the device development 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 work on Quality Management System activities, quality oversight of our suppliers, and host inspections.

 

We are an international team of 23 passionate Quality Assurance experts with diverse backgrounds of which the vast majority is based in Hillerød, Denmark - and a small part of the Device R&D satellite in Seattle, USA. Along with the rest of the device development area, 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, we are looking for the candidate to provide Quality support to a combination device and its variants (device platform) in the development portfolio of Devices & Delivery Solutions in Novo Nordisk. The role is structured to work with many different stakeholders both internally in Novo Nordisk, and with outsourced development partners. The right candidate will be part of the development process from early innovation until launch, give input to project planning, and ensure project deliverables at each development phase.

 

Core responsibilities include:

  • Handling most situations independently, apply your subject matter knowledge and identify better practice and drive improvements to Quality Assurance processes 
  • Playing an active role in sharing knowledge and learnings and thereby letting your colleagues learn and shine.
  • Taking part in the development of our Quality Management System. 
  • Providing active assistance during authority inspections and internal audits, both in the practical setup and in backing the projects in presenting documentation.

 

Quality Assurance Engineer will be responsible for facilitating our development projects in 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. The ability to find the best way of achieving both quality and other project objectives, and to set a clear direction is a key responsibility as a Quality Assurance Engineer.


Qualifications:
To fulfil the role, we expect:

  • An engineering, pharmaceutical, chemical, or other relevant academic degree and a strong quality mindset. 
  • At least 5 years of experience in design control and compliance in a medical device context
  • Working experience with aspects of design control such as design input, design output, design verification, design transfer, and design changes
  • Experience in interpreting regulatory requirements and preferably well versed in regulatory requirements and standards such as 'The Quality Systems Regulations' (21 CFR 820), 'Regulation of Combination Products' (21 CFR part 4), ISO 13485 'Medical devices - Quality Management Systems Requirements for Regulatory Purposes' and ISO 14971 ' Medical Devices - Application of Risk Management to Medical Devices'
  • Fluency in both written and spoken English on a professional level
  • Experience in active participation and leading audits

 

In addition, some of your strengths are to constructively engage your stakeholders and navigate in cross organisational stakeholder landscapes. You have ability to quickly understand situations and dilemmas and are solution oriented in introducing innovation within procedural and regulatory constraints along with translating regulatory guidance into operational practice to furtherance the development of devices. Clear communication and use of facts to present your point of view when needed to ensure regulatory compliance or patient safety is highly required, as well as being able to notice when our processes can be improved and have the drive to make change happen.

 

Contact
For further information, please call Dean Kloe at 30758948 or Mikkel Avlund at +45 3075 7095.

 

Deadline
6 October 2021
You do not need to attach a cover letter to your application, but please include a few sentences in your resume or CV about why you are applying. To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
 

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.