Are you ready to work in a rapidly growing Biotech start-up? And do you imagine yourself being a part of a dynamic international team? Then we are excited to see what we can accomplish together when your skills, ideas, and perspectives meet ours!

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.

About us 

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. 

The job 

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. 

Responsibilities

• Maintaining BluSense Diagnostics' Quality Management System according to ISO 13485:2016
• Creating/Updating new documents for the QMS (e.g. working instructions, standard operating procedures or forms)
• Performing activities related to QA oversight of manufacturing and guidance/training of manufacturing staff
• Reviewing and approving executed batch records
• Handling of Change Control
• Handling of non-conformity and performance of root cause analysis
• Helping to facilitate the CAPA process
• Review and approval of validation processes activities (manufacturing processes and IQ, OQ, PQ)
• Supporting the team in process and equipment validation
• Assisting with Supplier Management activities
• Assisting in audits (internal, external and supplier) 

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
• Experience with Regulatory Affairs is desirable 

Experience of the following aspects of Regulatory Affairs is desirable

• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.
• Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
• Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.
• Prepare or maintain technical files as necessary to obtain and sustain product approval. 

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

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 (dermot.oconnor@blusense-diagnostics.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.