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1928 Diagnostics Göteborg Heltid

Quality engineer

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About the job

We are looking for a quality engineer who will focus on quality assurance within 1928 Diagnostics development projects, that will ultimately result in software services launched on a global market. You will have an active role being an important part of the team where you, apart from your own delivery of processes and documentation, will act as an advisor and support the team in quality issues.

1928 Diagnostics has started the journey of building a certified quality system according to ISO 13485. You will be a key person in the implementation and maintenance of this system. As a person we need you to be structured, organized and efficient. You are expected to communicate well and enjoy working in a team. You also need to be able to work independently and be confident with addressing new challenges. All documentation will be in English.

You need to have a relevant academic education and we find it qualifying if you have some experience within medtech (software and/or IVD) with knowledge about ISO 13485, ISO 14971, IEC 62304 and QSR (21 CFR Part 820). You also need to have very good English skills.

Work task examples:

  • participate in development projects with focus on quality assurance
  • documentation and handling of technical files for the different products
  • write and revise routines, work instructions and templates
  • risk management
  • perform and support internal revisions
  • regularly summarize and analyze quality data.

You will work in our office in Gothenburg and have the opportunity to travel to trade shows, customers and collaborators.

  • Förmån: Competent and fun colleagues Competent and fun colleagues
  • Förmån: Responsibility Responsibility
  • Förmån: Flextime Flextime
  • Förmån: New technologies New technologies
  • Förmån: Stock opportunities Stock opportunities
We are a startup, crunching DNA data in the cloud, to help healthcare providers fight antibiotic resistance

1928 is a Swedish company based in Gothenburg with strong ties to both the tech and science community, bridging knowledge from biology and medicine into software development. Our mission is to use technology to build important services that can be used in healthcare to address the growing and alarming problem of antimicrobial resistance. Sweden is our homebase, but we are operating globally, and look forward to meet you wherever our paths will cross.

Join us in the fight against antibiotic resistance!

We are a cross functional team of 14 people on a mission to fight one of today’s largest threats against human health, antibiotic resistance. By offering cloud software services that analyses DNA from infectious bacteria, we can help hospitals to track down antibiotic resistant bacteria and support the physician in choosing the correct antibiotic treatment for the patient and support outbreak management and surveillance.

The company was founded by three scientists and a serial entrepreneur in 2014. From 2019 an onwards we are commercializing our products globally. In 2018, 1928 Diagnostics was awarded as Technology Pioneer by World Economic Forum, for our innovative technology that is poised to have a significant impact on global health, society and business.

We have a strong team spirit and enjoy spending time together at the office. Working hours are flexible and working from home now and then is common. Delivering according to timelines is important. The organisation is flat and each person holds responsibility for their own work.

Apart from doing good for the world we also embrace openness, diversity, creativity, collaboration, new technology and having fun. We are continuously growing and looking for people with a positive attitude that get things done.

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