Quality Engineer Risk Management ISO 14971

Job Location	Whiteknights
Education	Not Mentioned
Salary	£45,000 - £55,000 per annum
Industry	Not Mentioned
Functional Area	Not Mentioned
Job Type	Permanent, full-time

Job Description

Quality Engineer - Risk Management ISO 14971Location: Reading£45-55k Depending on experienceC4SSearchs client is looking to hire a qualified and experienced Quality Engineer - Risk management.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).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. 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.

Teamwork oriented and ability to coordinate.

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