Global QA Manager R&D

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Manage a team of 5-8 Quality Specialists / Engineers responsible for Design Control activities across the global organization. Interact with a wide variety of departments across the globe, including R&D, Manufacturing, Life Cycle Management, Global Quality Systems, etc.Role Functions; Provides effective leadership, and responsible for Quality tasks related to Concept Feasibility, Design Control and Risk Management activities.Manages all local QMS systems, such as Internal Audits, Supplier Quality, Equipment/Process/Software Control, NCR, CAPA, Document Control, Quality Control, Management Review, Data Analysis, Training and Batch Record Review processes.Works closely with Research and Development functional groups to ensure compliance to applicable standards (external and internal) such as ISO13485, MDR and MDSAP.Reviews and approves projects' Concept Feasibility, Design Control, and Risk Management documentation; Provides leadership to support product transfers and launches in compliance with applicable standards and procedures.Qualifications and Knowledge; Technically sound in quality systems, and knowledgeable of developments in the Quality Assurance field.Experienced with practical application of ISO 13485:2016, 21 CFR Part 820, MDR, and ISO 14971:2019Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools. Six Sigma Green Belt and/or Certified QE a plus.Experience with Usability Engineering per BS EN 62366 is a plus.Knowledge of: MS-Office, Minitab, and Agile. 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