Senior Quality Engineer - Risk Management


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

8th July 2021

Location

England

Salary/Rate

£45000 - £48000

Type

Permanent

This job has now expired please search on the home page to find live IT Jobs.

Reporting to the Development Quality Engineer Manager, the successful candidate shall be responsible for the quality and regulatory activities associated with IVD assays and Quality Controls through the design and development, verification and validation, transfer to manufacturing and release and post market phases.Key Roles and ResponsibilitiesEnsuring that all Risk Management Procedures are conducted in compliance with ISO 14971 Medical devices. Application of risk management to medical devicesEnsuring that all Risk Management activities are conducted appropriately to fulfil the requirements of IVDR 2017/746 for Notified Body submission for CE marking and other global regulatory submissionsEnsure that a robust process is in place so that all Post Market surveillance data is integrated back into the Risk Management activitiesSupport the transfer of product from R&D to manufactureSupport the creation of the technical files for CE markingInternal audits, NCs, CAPAsWorking with the assay development teams to ensure that risk management activities are initiated early within the design and development processes and drive the design process throughout the whole lifecycle of the productWork with individual assay development teams as a quality and regulatory supportWork with the Technical Leaders and Project Managers to maintain quality throughout the Design and Development processSkills & ExperienceKnowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.Experience of Risk Management in an IVD or Medical Device environmentExperience of working in an IVD or medical device environment with a strong quality and regulatory focus and experience through development and verification and validation activities.Experience of pre and post launch IVD or medical device activitiesScientific background.Excellent organizational skills for working on multiple projects.Ability to use problem solving tools and methodologies.Influence internal project team and external parties to maximize success opportunities.Desirable skillsScientific degreeExperience of working on regulatory submissions To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

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