Senior Design Quality Engineer
Hobson Prior are looking for a Senior Design Quality Engineer to join a top speciality measurement company in Cheshire. This position will support the delivery and full lifecycle management of software.
- 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.
- Provide guidance on Product Software development process activities and related workflows in relation to regulatory compliance, provide 'solution-based' problem resolution.
- You will 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.
- Evaluate the acceptability of products for release, ensuring customer requirements /specifications and internal policies and procedures are met.
- Participate in assigned reviews related to software design and development, including design, project, business and governance.
- Act as subject matter expert in relation to software design and development ensuring conformance and up-to-date information on applicable regulatory requirements including as appropriate ISO 9001, ISO 62304, ISO 62366, ISO 14971 and ISO 13485.
- Minimum of Bachelor's degree, Computer Science, systems engineering or related Engineering degree preferred OR extensive proven experience within a regulated occupational environment.
- Strong working knowledge of various Software Development Life Cycle models within a complex hardware-software development environment.
- Experience of working with 'Agile' methodologies.
- Advanced 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 an ISO 9001 environment.
- Desired - Extensive experience in new product development focused on software / quality engineering related activities in a medical device environment.
- Desired - Previous experience of executing quality assurance activities supporting software development in a regulated environment - ISO 9001, ISO 13485, ISO 62304.
- Desired - ISO 9001 internal auditor certification.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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