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Danaher Corporation
,
Newcastle upon Tyne, Tyne and Wear
QA Officer - IVDR PMS
Overview
Job Description
Position Summary and Overview To support Leica Biosystems Newcastle on the IVDR project specifically in developing Post Market Surveillance (PMS) processes that meets the requirements of the new regulation. This will enable business compliance with IVDR requirements for PMS. Major Responsibilities + Creating, reviewing and updating quality system procedures and forms to meet the new requirements for IVDR. + Supporting the IVDR PMS work stream leader to develop IVDR compliant QMS documentation. + Developing PMS training materials + Assist IVDR PMS work stream leader with QMS training activities. + 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 actively employed to minimise waste and maximise efficiency at all times. Required Skills/Experience + Experience of working within a regulated environment is desirable, Quality Assurance experience - preferably medical device or IVD. + Knowledge of PMS under IVDD + Knowledge of ISO13485 and In Vitro Diagnostic Directive + 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. + Knowledge and understanding of LBS NCL product documentation and DHFs (desirable). + Proven and demonstrable experience in writing plans and reports (desirable). 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.