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QA Specialist

Do you want to work in a dynamic and growing med-tech startup? Are you ready to be a key player in the QA team with a real impact on the products and processes? If yes, you might be a new colleague to our team that we are looking for! 

 

About us

BluSense Diagnostics is an innovative company in the MedTech business, and 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, hardware and software engineering in developing the next generation of point-of-care testing for infectious diseases.

The position

As a QA Specialist you will take an important and active role in supporting/driving all aspects related to quality assurance of BluSense’s point-of-care testing products. You will work in close with all departments of the company and  ensure that all quality standards are met.

As a QA Specialist, you will:

  • Support QA Manager in maintaining the Quality Management System and Quality Policy, and identify areas of improvement
  • Lead the maintenance and training in our newly implemented Electronic Quality Management System and support your colleagues with its use and functions
  • Create, review, and continuously improve our QMS documentation (e.g., Standard Operation Procedures, Work Instructions and Forms)
  • Handle and Monitor progression in Deviations, CAPAs, Change Control as well as perform root cause analysis and risk assessments
  • Support in release of products, (e.g, review, and release of batch records)
  • Perform internal audits, as well as take active part in coordination of external audits
  • Review and approving process validation activities (manufacturing processes and IQ, OQ, PQ)
  • Support R&D during the development and documentation of novel products
  • Assess, approve, and maintain suppliers incl. ongoing evaluations
  • Support post market and vigilance team in complaint handling
  • Support in implementation of new regulatory standards

About you

We are looking for a structured person with a right quality mindset, who is ready to be part of our continuous effort in implementing high QA standards and cultivating that attitude across departments. You need to be an excellent communicator and build relationships with both internal and external stakeholders.

You are a positive, cooperative, outgoing, and curious professional, who is self-driven and ready to challenge the way we work and take a lead in driving and implementing changes.

Additionally, you have:

  • Minimum Bachelor’s degree in science, pharmacy, chemical engineering, or medical field
  • At least 2 years’ experience in a similar role in a regulated industry (e.g. medical devices, IVD)
  • Knowledge of ISO 13485:2016, GMP, directive 98/79/EC and IVDR
  • Ideally Certified Lead Auditor for ISO 13485:2016
  • Fluency in English, both verbally and in writing
  • Ability to manage projects and adhere to timelines
  • International experience is a plus

What we offer

  • A challenging and dynamic working environment
  • Co-operation and exchange of ideas within a multinational and interdisciplinary team
  • You’ll have a leading role in bringing to market a novel point-of-care device
  • Learning and growth opportunities within the organization

 

Application

If you are interested in the position, apply no later than February 28th, 2021. Interviews will be held on an ongoing basis, so we encourage you to apply as soon as possible.

Ideally, a chosen candidate can take up employment as soon as possible.   

For questions regarding this position please contact Robert Burger, COO (robert@blusense-diagnostics.com).


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