Quality Engineer (Medical Devices)
Quality Engineer Eden Scott's client based in the central belt is a specialist medical device company revolutionising, in-vitro diagnostics through flexible assay technologies. As the business draws closer to their product launch they are looking for a talented Quality Engineer to join their team. The candidate: The ideal candidate will be educated to degree level in a relevant scientific/engineering discipline with several years' industry experience behind them. Individuals with specific IVD instrumentation and/or experience in electromechanical medical device Hardware and software projects would of considerable interest. A good problems solver, team player and a continual Improvement mind set are prerequisites for this post. (PDCA, Kaizen, Six Sigma, Lean, and Value Stream Mapping etc.) The role: Reporting to the Regulatory Director, the successful candidate shall be responsible for the day to day QMS activities associated with IVD sensors (assays) and instrumentation 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 Creation of traceability matrices Organize, host and facilitate risk management related activities and design reviews with the project teams and ensure compliance of such activities to the applicable standards and regulations. Ensure compliance of documentation for design partners (and suppliers) within the supply chain. Support supplier approval and monitoring activities Prepare and create documents and records for upload on to GAS Review and approve as Quality representative on project teams and QMS Review and approve Device History Records and final product release Essential skills Knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CRF Part 820 Experience of working in an IVD or medical device environment with a strong quality focus in development and verification and validation activities Experience of post launch IVD or medical device activities Ability to use problem solving tools and methodologies In return you can expect a competitive salary + benefits and play a key role in the company's future success with many development opportunities available for the right individual. Don't miss out on this fantastic opportunity, apply now. To discuss this role in more detail, call Keith Tocher on 01315501130 If this role isn't quite what you are looking for, register your CV at and be the first to hear about our latest opportunities by signing up for our job alerts.