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.
You will also handle projects and tasks related to risk management activities, from product inception through product launch and maintenance and play an active role in the processes to ensure products meet quality standards consistent with both Corporate and business unit policies, while meeting all design control and other regulatory requirements.
As Quality Engineer – Risk Management you will;
Provide Risk Management technical expertise through the product life cycle.
Develop or remediate 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.
Facilitate development and completion of risk assessments for field issues/complaints in the field.
Work with all production and post-production functions to ensure the proper application, use and updates of risk management files.
Work with Clinical personnel on creation of appropriate harm/hazard analysis for issues potentially impacting patient outcomes.
Keep up to date on new regulations and standards that affect Risk Management for medical devices. Ensure Risk Management procedures, processes and files are updated where required.
Participate to continuous improvement efforts, through collaborating with cross function teams.
The successful candidate will have the following attributes;
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.
Excellent communication and writing skills, this role will require writing quality reports and presentations for executive management and auditors.