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    Software Quality Assurance Engineer (Mobile Apps, Algorithms, Web Apps) at Abingdon Health (York, UK)
    Abingdon Health Employer
    York, UK
    Job Type
    Job Location
    Full Time
    York, UK

    Job Description:

    Primary Duties and responsibilities:



    • Design, adapt, develop and document process for ISO 62304 and/or ISO 9001:2015 compliant software development.

    • Applying software development skills to the entire product development lifecycle of IVD software in a new and progressive environment

    • Help evaluate and validate quality management software for software development lifecycle.

    • Maintain documentation for compliance with the help of technical team and project manager.

      • Product/software requirements, test specifications and reports

      • Risk analysis and management documents

      • Software configuration and release management



    • Help identify scope and risk class of the software according to product requirements.

    • Design, maintain and adapt templates for variety of documents using either office software suites or specific QMS software.

    • On occasion also help to perform same work for lateral-flow assay reader instrumentation.

    • Work with the QARA director as interface for the technical team


    Essential



    • Master’s or Bachelor’s degree in Computer Science, Information Systems or equivalent)  

    • 2-3 years relevant industry experience

    • Experience of designing, planning and executing software tests within a software validation framework

    • Prior experience developing software in a regulated environment (such as ISO 13485/IEC 62304 a bonus)

    • Sound understanding of a structured software development life cycle (such as ISO 62304)

    • Experience working within smartphone and web app development teams

    • Knowledge and understanding of GDPR

    • Familiarity with QMS document management tools and workflows


    Desired



    • Exceptional communication skills in English

    • Demonstrable excellence in problem solving within fixed timelines

    • Flexibility and the ability to effectively manage multiple concurrent projects

    • Ability to work within multidisciplinary team of developers, scientists, engineers.

    Benefits:

    Certificate
    Flexible Hours
    Letter of Recommendation
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