BluSense Diagnostics is a young and dynamic MedTech company, spin-off in 2015 from the Department of Micro- and Nanotechnology, Technical University of Denmark. The company is developing a point-of-care blood testing device for infectious diseases, based on a novel nanotechnology-based biosensing method, leveraging hardware and consumables developed from the optical storage industry.

We are looking for a  QA manager who will take a leading role in all aspects related to quality assurance of BluSense’s point-of-care testing products.

Do you want to work in a rapidly growing med-tech startup and make a real impact on the lives of people affected by dengue, Zika and other tropical diseases? Can you imagine yourself being a part of a dynamic, international team with colleagues from more than 17 countries? If yes, wait no longer and apply now! We are excited to hear from you!

The position:

You will take a leading role in all aspects related to quality assurance of BluSense’s point-of-care testing products. You will work in close collaboration with management, R&D and production to ensure that all quality standards are met at BluSense Denmark, where ViroTrack cartridges are developed and produced. Furthermore, you will provide support to the quality assurance team at our subsidiary BluSense Biotech in Taiwan, where hardware and software development and manufacturing is performed.

Responsibilities:

•    Improve and maintain the Quality Management System and Quality Policy in cooperation  with Top Management
•    Responsible for managing the overall quality at BluSense Diagnostics
•    Coordinate and supervise quality related activities at our subsidiary BluSense Biotech in Taiwan (occasional travelling might be required)
•    Ensure that all applicable quality requirements are clearly defined and implemented supporting the effective Design transfer of new/updated products from R&D into Manufacturing
•    Assure that the assigned product portfolio and applicable processes and procedures remain in compliance with IVD regulatory and ISO 13485:2016 Quality requirements
•    Review all current inspection and testing protocols utilized within the assigned product portfolio and develop continuous improvement initiatives to assure that all design control document templates are efficient, effective and fit the purpose and are simple to use
•    Assist R&D in defining the quality requirements in the evaluation of new or alternatively sources for components and monitor/evaluate manufacturing trial activities
•    Conduct internal Quality audits and coordinate external Quality audits
•    Collaborate cross-functionally with R&D and Manufacturing to resolve product life cycle quality issues
•    Ensure that all quality KPIs are kept current and ensure the product/process quality feedback to the organization in a clear and standardized way
•    Ensure that Quality Management Reviews are prepared and carried through regularly
•    Ensure maintenance of the QMS system and ensure regular training and development of the organization
•    Supporting R&D during the development and documentation of novel products
•    Investigate and Manage all internal and external discrepancies (non-conformance, CAPAs, etc.) are adequately documented, registered and resolved in alignment with internal procedures
•    Occasional travelling will be required, both within Denmark and internationally

Qualifications:

•    You are highly motivated and can work well alone but also as part of a team.
•    Minimum Bachelor’s degree in science (biology, chemistry, medical technology or other), engineering or medical fields
•    At least 2 years of experience in a similar role in a regulated industry (e.g. medical devices, IVD)
•    Knowledge of ISO 13485:2016, directive 98/79/EC and IVDR
•    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
•    You like to work in a fast-paced start-up environment
•    International experience is a plus

•    A dynamic working environment
•    Co-operation and exchange of ideas within a multinational and interdisciplinary team
•    You will have a leading role in bringing to market a novel point-of-care device

How to apply:

We will process applications as they arrive. Therefore, please submit your application and CV as soon as possible and no later than April 1st. Qualified applicants can expect to be called for an interview before the deadline.

Send us your application via the hub. For questions regarding this position please contact Robert Burger, COO (robert@blusense-diagnostics.com).