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QA Specialist for Manufacturing

Full-time, Copenhagen
Monthly salary:

Competitive

BluSense was founded in 2014 as a spin-off from the Technical University of Denmark (DTU). It is a global-born start-up with operations in Denmark, Taiwan and Malaysia. Our core technology is built around a patented immunoassay detection technology based on the use of nanoparticles.

View more about BluSense Diagnostics ApS

Keywords

QA SpecialistmanufacturingQA

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Are you a highly motivated specialist that thrives in a start-up environment and can work well alone as well as part of a team?

Do you have 2-3 years of experience in quality assurance related to IVD and manufacturing?

Would you enjoy working in an international environment with 35 other colleagues from 15 different nationalities? 

If you answered 'YES' to all three of these questions, then you could be the QA specialist for manufacturing BluSense Diagnostics is looking for!

The position:

You will take a leading role in all aspects related to quality assurance of manufacturing of BluSense’s point-of-care cartridges. You will be involved in various daily operational tasks in a dynamic and challenging environment.

Responsibilities:

  • Maintenance of BluSense Diagnostics’ Quality Management System according to ISO 13485:2016
  • Creating new documents for the QMS (e.g. working instructions, standard operating procedures or forms)
  • Performing activities related to QA oversight of manufacturing and guidance of manufacturing staff
  • Reviewing and approving of executed batch records
  • Handling of Change Control
  • Handling of Deviation
  • Handling of Non-Conformity and performance of root cause Analysis
  • Handling of CAPA
  • Reviewing and approving validation processes activities (manufacturing processes and IQ, OQ, PQ). 
  • Supporting the team in process and equipment validation
  • Supplier Approval
  • Assisting in audits (internal/external)

Qualifications:

The ideal candidate should demonstrate the following qualifications:

  • Minimum Bachelor’s degree in science (biology, chemistry, medical technology), engineering or medical fields
  • Minimum 2-3 years’ experience with Quality Assurance of manufacturing within Medical device, preferably IVD
  • Experience and strong knowledge of ISO 13485:2016 
  • Review and evaluation of Master and Batch Production Records

Personal Skills

  • Fluency in English, both verbally and in writing
  • Ability to manage projects and adhere to timelines
  • Ability to work in an international environment with cross-functional teams
  • Ability to work in a fast-paced start-up environment

We offer

  • Work in a young, international and highly motivated team
  • Have a leading role in bringing to market a novel point-of-care device
  • Competitive salary


Interested? Apply now!


For further questions related to this position, please contact Siema Hussain, QA/RA Responsible (siema.hussain@blusense-diagnostics.com,  +45 39 17 97 15).

We will process applications as they arrive. Therefore, please submit your application and CV as soon as possible and no later than February 17th. Qualified applicants can expect to be called for an interview before the deadline.

Perks & Benefits

Free coffee / tea: Get your caffeine fix for free
Located near public transit: Easy access and treehugger friendly workplace
Social gatherings and games: Hangout with your colleagues
Free beer on Fridays: Friday is something special, let's enjoy a beer together
Maternity / paternity leave: Kids are the future, go spend time with them

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