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Danaher Corporation
,
Newcastle upon Tyne, Tyne and Wear
QA Officer - Risk
Overview
Job Description
Major Responsibilities + 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. + 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. + 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. + Ensure that DBS learning's and tools are actively employed to minimise waste and maximise efficiency at all times. Required Skills/Experience + Experience in relevant/appropriate scientific domain + A track record of achievement and an ability to ensure accountability to ensure business needs are met on a sustained and timely manner. + Proven and demonstrable experience in information and literature searching + Proven and demonstrable experience in writing plans and reports + Proven and demonstrable experience in project management + Experience or relevant understanding of + Cellular Pathology and immunohistochemistry / in situ hybridisation principles + Experience of working within a regulated environment (desirable) + Knowledge and understanding of LBS NCL product documentation and DHFs (desirable). Competencies + Must possess strong interpersonal, communication and influencing skills. + Strong, independent worker capable of operating in a fast-paced, constantly changing environment. + A self-starter able to manage their own workload and prioritise tasks accordingly + Able to work on multiple projects/investigations concurrently + Must be highly motivated with a positive and enthusiastic approach to work + Must be results oriented + Excellent organisational skills + Excellent project management skills + Excellent time management + Excellent attention to detail Education List of Education, Certifications, Training Desirable but not necessary: - + Degree (or equivalent) within a relevant Biomedical Science subject + Further degree (PhD or MSc) would be advantageous. n/a 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.