Stem Recruitment have a fantastic new opportunity for someone with strong quality software experience with a medical background.
Reporting to the Quality and Regulatory Director, the successful candidate shall be responsible for the day to day QMS activities associated with IVD instrumentation and software throughout the product lifecycle including the R&D phase the verification and validation phase, manufacturing and product release. Activities such as document/process creation, review and approval of documents and working with all project teams to guide the teams in the day to day use of the quality management system and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the lifecycle.
Key Roles and Responsibilities
·Quality representative for project teams throughout product lifecycle and product realization activities
·Creation and management of documentation forming the Design History File and Device Master Record.
·Assess, control and coordinate changes to Design History File and Device Master Record.
·Coach and support in the writing of design requirements and specifications.
·Coach and support in the writing of Verification and Validation plans and protocols
·Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, ISO62304, FDA 21CFR Part 820.
·Experience of working in an IVD or medical device environment with a strong quality focus and through development and verification and validation activities, ideally with a focus on software
·Knowledge and experience in medical device software projects
If this is of interest, please get in touch