Quality Operations Team Lead
leeds, west yorkshire, yorkshire and the humber, United Kingdom
Tata Consultancy Services
areas on relevant IQ/OQ/PQ protocol issues. Lead site wide activities aimed at maintaining Part 11 Compliance. Assess the need for risk mitigation techniques based on product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these … in good order all relevant sections of Device Design History File and DMR as directed. Develop and utilize DFMEA/PFMEA and other QA risk analysis techniques to minimize potential risk during development/implementation activity. Work with Production and Technical Support to develop and implement appropriate … skills/knowledge/experience: Good technical understanding of manufacturing equipment and processes is required. In-depth knowledge and experience of product/process Risk Management (FDA and ISO standards). Technical training and experience using Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis More ❯
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