Role Title Senior Design Quality Engineer (R&D) Location Hull Rewards Competitive salary and comprehensivebenefits on offer Summary We have an exciting opportunityfor a Senior Design Quality Engineer working with a wide variety of departmentsand teams.
You will play a pivotal role in Design Control and Change Controlprojects, having overall responsibility for assuring that products are designedand maintained in a manner compliant with all applicable global Quality SystemRegulations.
This includes the creation and maintenance of design history filesand risk management files for Smith and Nephew medical devices throughout theproduct lifecycle.
EssentialJob Functions Provision of quality leadership to new productdevelopment and sustaining project teams as the quality engineeringrepresentative.
Work with the team todevelop methods and procedures to ensure that the appropriate tests areconducted to meet the required design.
Generate, approve and / or manage design verificationand validation activities. Actively participate in and / or facilitate thedevelopment, review and approval of requirements and deliverables to supportmedical device product software development.
Provide support to Operations teams to ensuresuccessful transfer of the design and design controls to manufacturing.Support continuous improvement activities includingCAPASupport Post market surveillance activities,Management review, Audits and inspections.
To perform all activities in compliance withrelevant GMP, Smith & Nephew Quality Systems and safety standards and withFDA Quality System Regulation and ISO 13485.