Software Development Quality Assurance Engineer
10 month fixed term contract
Large global company
- Assume a Subject Matter Expert (SME) role on Product Software development process activities and related workflows in relation to regulatory compliance, provide 'solution-based' problem resolution
- Act as Quality specialist in relation to software design and development ensuring conformance and up-to-date information on applicable regulatory requirements including as appropriate ISO 62304, ISO 62366, ISO 14971 and ISO 13485.
- Provide interpretation and guidance on industry best practice Software Development Life Cycle (SDLC) methodologies - mentor/train personnel involved in software development in respective to "Best Practices".
- Provide leadership and direction on all quality activities necessary for the project team to achieve design control deliverables, specifically deliverables related to product safety, usability, risk management, compliance and product performance.
- Actively participate in and/or facilitate the development, review and approval of requirements and deliverables required to support product software development (planning, requirements, architecture, verification/validation etc.) including software risk management, maintenance, configuration management and problem resolution.
- Strong working knowledge of various Software Development Life Cycle (SDLC) models within a complex hardware-software development environment.
- Extensive knowledge of and use a variety of software risk management tools, design and process control activities, usability and validation testing methodologies to drive software product quality for new product development in a ISO 9001 environment.
- Demonstrated ability to apply system quality management practices in efficient and effective ways while ensuring compliance. Solutions-based approach to quality, wants to provide "added value".
- Minimum of Bachelors degree [BSc], Computer Science, systems engineering or related Engineering degree preferred.
- Desired - Extensive experience in new product development focused on software / quality engineering related activities in a medical device environment.
- Desired - Previous Senior Management experience of leading quality assurance activities supporting software development in a medical device environment - ISO 13485, ISO 14971, ISO 62304, ISO 62366 and applicable good manufacturing practice regulations including, 21 CFR part 820.