Software Quality Assurance Engineer/Lead Abingdon Health – York

Type: Permanent.

Start Date: Immediate.

Location: York, United Kingdom with remote work possible.

Overview

Abingdon Health is mobilising its rapid test operations in order to scale-up the deployment of rapid diagnostic solutions in response to the global COVID-19 outbreak. Due to significant demand for our
services we are recruiting for experienced personnel to join our team immediately.

Abingdon Health is a global leader in the contract development and manufacture of lateral flow rapid tests and reader systems, working on behalf of global clients across many industries. Our instrumentation and app development team have developed benchtop readers and Smartphone based next-generation reader technology, such as Abingdon Health’s AppDxTM platform.

AppDxTM uses proprietary technology to enhance rapid test results to make monitoring simpler, low-cost and traceable. AppDxTM is a game changer in rapid-testing with its ability to capture complimentary data,
such as GPS mapping, patient ID and date stamping, for analysis in a central cloud or data-hub.

Thus allowing stakeholders to access and analyse data as part of a streamlined diagnostic process for improved and faster outcome management.

Our team offers you the chance to work on solving challenges not only in quality assurance also in but design, management and technical domains. You will develop and learn new skills and techniques and gain
tangible experience working in a highly multidisciplinary environment.

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 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 workflow

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.

For all enquiries concerning career opportunities please email recruit@abingdonhealth.com with aCurriculum Vitae (CV).

About Abingdon Health

Abingdon Health is a UK-based developer and manufacturer of lateral flow tests and smartphone
reader solutions. Abingdon Health offers development and manufacturing services for customers
looking to develop new assays or looking to transfer existing laboratory-based assays to a lateral
flow format. Abingdon takes projects from initial concept through to routine and large-scale
manufacturing.

Abingdon Health is headquartered in York, England.

For the original job advert please see here.

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