A global medical technology company near Reading is recruiting a highly motivated, results-focused Quality Engineer – Risk Management in the newly created Risk Management team.
As Quality Engineer – Risk Management, your primary responsibilities are to support the risk management process and to provide expertise for project teams in relation to compliance to standards (EN ISO 14971:2012, EU MDR). In addition, you will be conducting analysis and investigation of product or quality system issues intended to support projects and continuous improvement surrounding the quality of products and systems.
Provide Risk Management technical expertise through the product life cycle.
Develop and maintain Risk Management Files according to ISO 14971 and MDR requirement; and ensure Risk Management Files are updated per defined schedules and frequencies.
Work with R&D and Sustained Engineering on the development and incorporation of Risk Management and compliance to standards during all design phases for new and/or product enhancements.
Experience required include:
BEng in technical field, or equivalent, and industry experience.
Direct experience with medical devices in a regulatory environment. Infusion pump hardware/software/disposables experience is preferred.
Strong knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, 21 CFR, EU MDR requirement, EN ISO 14971:2012, IEC 60601-1, ISO 13485, EN 62304, IEC 62366, FDA Guidance – Cyber Security, interoperability, assurance cases etc.) to the R&D environment.
Must be able to apply quality principles (GMPs, 21 CFR, etc.) to the R&D environment.