We are looking for a highly skilled and ambitious QA Specialist with some Regulatory Affairs exposure who can secure high quality standards in our production of next-generation diagnostic devices for infectious diseases.
BluSense Diagnostics is an innovative start up in the MedTech business! We work hard to become global leader within the Infectious disease point-of-care diagnostics. We combine complex scientific areas such as nanotechnology, biochemistry, optics, and hardware and software engineering in developing the next generation of point-of-care testing for infectious diseases.
We are looking for a QA Specialist who can strengthen the quality assurance across all aspects of the business, including manufacturing and R&D support. Your job will focus on ensuring the quality of multiple products manufactured at BluSense in Copenhagen.
As an ideal candidate you will have in-depth knowledge about high-throughput manufacturing lines, quality controls, process development and validation, microfluidics assembly, biochemistry and reagents quality control and medical device regulations and standards (such as Directive 98/79/EC, IVDR and ISO 13485:2016).
You will work closely with our quality team to assist production and R&D in relation to all aspects of quality assurance for BluSense's point-of-care cartridges as well as assisting the QA Manager with compliance related activities. Furthermore, you will work directly with the quality team to facilitate manufacturing processes improvements using various methods of testing and inspection. You will also be performing daily quality checks, incoming goods inspection, and sampling during production in a dynamic and challenging environment.
Experience of the following aspects of Regulatory Affairs is desirable
Please use you cover letter effectively to tell us more about your experience relevant to Quality and/or Regulatory Affairs.
Contact Dermot O’Connor, QA Manager (email@example.com +45 31 33 48 89). for any questions.
Please apply via The Hub.
We will process applications as they arrive. Therefore, please submit your application and CV as soon as possible. Qualified applicants can expect to be called for an interview before the deadline.
This job comes with several perks and benefits
Get your caffeine fix to get you started and keep you going.
Easy access and treehugger friendly workplace.
Social gatherings and games; hang out with your colleagues.
Friday is something special, let's enjoy a beer together.
Kids are the future, go spend time with them.