Quality Systems Manager, Gothenburg, Sweden

- Join us in the fight against antibiotic resistant bacteria!

At the forefront of digital health, 1928 Diagnostics strives to bring the full value of Bioinformatics and Cloud Computing to revolutionize how health care fights antibiotic resistant bacteria. 1928 Diagnostics is a start-up transitioning to the commercialization phase, already operating globally. The company was elected a World Economic Forum Tech Pioneer in 2018 for its innovative technology that is poised to have a significant impact on global health, society, and business.

We care about our cause. Antibiotic resistance is one of the top three largest threats against humanity. 1928 Diagnostics combines software technology and genomics to analyze DNA from infectious bacteria and help hospitals to track down antibiotic resistant bacteria and enable the right treatment to the patient.

Our product is used for research and within microbiology labs that often are certified under ISO 15189/CLIA. Product performance, quality, data privacy and security are very important to our customers. To meet these requirements, quality and information security management systems are essential. We are working towards external certifications within these areas. Therefore, to further enable our growth we need an experienced Quality Systems Manager that can lead the implementation and maintenance of our management systems in compliance with ISO 900113485 and ISO 27001. You will report directly to the QA/RA Director and be encouraged to take a great responsibility and be the driving force behind building and maintaining our management systems.

Main responsibilities

  • Implement and maintain a functioning Quality Management System.
  • Plan and perform internal audits.
  • Evaluate audit findings and participate in implementing appropriate corrective actions.
  • Collect, compile and analyze quality data (product and process).
  • Manage KPIs to ensure quality focus and continuous improvement.
  • Identify training needs and organize training in applicable processes within the management systems.
  • Promote awareness of applicable regulatory requirements and management systems within company.

Qualifications

  • BSc/MSc in Quality management, Software engineering, Microbiology, Bioinformatics or similar is required.
  • Minimum 5 years of experience from the life science, diagnostics, medical device or pharmaceutical industry.
  • Lead Auditor.
  • Excellent command of English - both spoken and written.

You are results-oriented and have great project management and organizing skills with a strong attention to detail. You have most likely worked within the life science sector with management systems. We think you can work efficiently in multidisciplinary teams or alone. We value experience with software development, IVDR/MDR, ISO 15189/CLIA, and IT security.

1928 is a growing scale-up company and you must enjoy working in a small and evolving company environment. You will work in our office in central Gothenburg and will have the opportunity to travel to trade shows, customers and collaborators.

We believe you have a great drive to make a difference, for 1928 and to save the power of antibiotics.

Applications

To apply, please submit your CV and cover letter at jobs@1928diagnostics.com.

For more information regarding the position you can also contact:

Robert Engberg QA/RA Director +46 702 96 96 86