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
- 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
- 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.