Quality Engineer – Risk – ISO 14971 – £50,000 – Winnersh

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Quality Engineer – Risk – ISO 14971 – £50,000 – Winnersh

Permanent

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.

Responsibilities include:

  • 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.

Keywords: risk, quality, GMP, CFR, MDR, FDA, 14971, 13485, 62304, 62366

Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency

Job Reference: BBBH13719

Salary: Up to £50000 per annum

Salary per: Annum

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Bond Williams Professional Recruitment are an equal opportunity employer and operate as an Employment Business and Recruitment Agency

Peter Knibbs
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