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Danaher
,
Newcastle upon Tyne, Tyne and Wear
QA Officer - IVDR
Overview
Job Description
We're looking for a QA Officer to support our team at Leica Biosystems in Newcastle, initially on a one year fixed term contract basis. The purpose of this role is to provide support with the IVDR project with the compilation and review of Risk Management Files for existing LBS NCL IVD products. This will enable business compliance with IVDR requirements for risk management. In this role you'll * Assisting with gap analysis for ISO14971:2019 and ISO/TR24971:2020 requirements. * Creating, reviewing and updating quality system procedures and forms to meet the new requirements for IVDR. * Coordinating risk management reviews; scheduling cross-functional attendance, preparing and collating documentation, ensuring completion of documentation to meet all requirements. * Working with technical scientists to provide a QA review of Scientific Validity Reports, Analytical Performance Reports, Clinical Literature Reports and Performance Evaluation Reports. * Providing QA support for IVDR labelling updates. * Ensuring projects are managed using the appropriate business processes to meet project objectives, timescales and budgets. * Working within the Newcastle Quality Management System to ensure activities are carried out through the Change Management, Non-Conformance and CAPA Processes (as applicable). * Ensure that DBS learning's and tools are always actively employed to minimise waste and maximise efficiency . What you'll need to do the job * Experience of working within a regulated environment is desirable, Quality Assurance experience - preferably medical device or IVD. * A track record of achievement and accountability, an ability to ensure business needs are met in a sustained and timely manner. * Proven and demonstrable experience in adhering to strict project deadlines. * Proven and demonstrable experience in writing plans and reports (desirable). * Must possess strong interpersonal, communication and influencing skills. * Strong, independent worker with ability to work on multiple projects. * Ability to manage own workload and prioritise tasks accordingly. * Excellent attention to detail. * Ability to use appropriate software tools including Word and Excel. Interested? Join the Leica Bio Systems Team! Want to join our growing team that is helping our customers do incredible work? We look forward to your application! Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The "EEO is the Law" poster is available here.