BluSense Diagnostics is an innovative startup in the MedTech business! We work hard to become a 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 ambitious Junior QA/QC Specialist who can secure high-quality standards in our production of next-generation diagnostic devices for infectious diseases.

The job

We are looking for a Junior QA/QC Specialist who can strengthen the quality control of our manufacturing activities. Your job will be to focus on ensuring the quality of multiple products manufactured at BluSense in Copenhagen. You will work closely with our quality team to assist production in relation to all aspects of quality control for BluSense's point-of-care cartridges. Furthermore, you will work directly with quality assurance to facilitate manufacturing processes for improvement 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.

Your responsibilities

• Assist with maintenance of BluSense Diagnostics' Quality Management System according to ISO 13485: 2016

• Help to create new documents for the QMS (e.g. working instructions, standard operating procedures or forms)

• Review of production documents (SOPs, WIs and Forms)

• Support activities related to QA oversight of manufacturing and training of manufacturing staff

• Support incoming goods control and raise complaints with suppliers if necessary

• Assist with inspection of final products, reviewing batch records and packaging records

• Assist when NC’s (Non-Conformances) occur in production, facilitate root cause analysis investigations in close cooperation with your colleagues

• Support inspections of the environmental conditions of the manufacturing areas and ensure that GMP (Good Manufacturing Practice) is adhered to (behavior, PPE, readout and recording of temperature loggers, check of EMRs, check equipment calibration)

• Support process validation activities including review of protocols/reports when needed

• Support QA with supplier management activities (sending out questionnaires, following up, filing documents)

• Assist in audits (internal and external)

• Inspect/Review/Screen product and materials as part of QA investigation (if needed)

• File QMS and production documents

• General administrative support/assistance for your QA colleagues and QA/RA Manager (on an as needed basis)

Your qualifications

• You are about to or have recently graduated with Bachelor's degree in production engineering, science (biology, chemistry, medical technology) or medical fields

• Knowledge of ISO 13485:2016 is desirable

• Experience drafting, authoring and reviewing SOPs

• Ability to write clear and concise instructions and to carry out trainings

• Knowledge of A3 problem solving or 8D methodology is a plus

Personal skills

• Fluency in English, both verbally and in writing

• Ability to make independent decision regarding quality related concerns or issues

• Ability to manage workload and adhere to timelines managing multiple conflicting priorities and deadlines

• Ability to work in an agile and fast-moving environment with cross-functional teams

• Ability to critically evaluate and troubleshoot complex problems together with colleagues and lead root cause analysis.

• Well-organized and detail oriented professional, with strong verbal and written communication skills

• Computer literate, competent in Excel, Word and Powerpoint

We offer

• Work in an international and highly motivated team

• One year-contract (maternity cover)

• Have a leading role in bringing to market a novel point-of-care device

• Competitive salary

How to apply  

We will process applications as they arrive. Therefore, please submit your application and CV in one pdf file via The Hub as soon as possible and no later than June 26th,  2020. Qualified applicants can expect to be called for an interview ahead of the deadline.

We plan to hire for a job start in July/August 2020.