Quality Manager

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Our client is a global leader in providing solutions for medical device diagnostics. They are growing quickly and constantly expanding the team. They are looking for a Quality Manager to join the team working with a diverse group of individuals that share a passion to do work that matters and positively impacts patient lives. The Quality Manager position will be responsible for driving improvement throughout the site in products and processes, to set up and maintain appropriate quality systems to drive product and process improvements, improved customer satisfaction, productivity and compliance.Drive reduction of customer complaints using solid investigation methodologies and root cause analysis expertise.Establish and monitor performance metrics, champion quality and customer focused initiatives.The Quality Manager will utilise in-house and externally obtained data to drive product improvements and reliabilityManage and continually improve all elements of the Quality Management System (QMS) including the following processes: e.g. Root Cause Analysis, Corrective and Preventive Action, Document Control, Change Management, Supplier Management, Acceptance Activities including Incoming Inspection, In process, and Finished Product inspections, Device History Records, Non-Conforming Records, and the Quality Hold process, Internal AuditsLead problem solving activities and implementation of permanent fix solutionsUtilising key process indicators (KPI's), promote and initiate continuous improvement initiatives that drive change within the business that result in cost effectiveness and/or revenue enablement.The Quality Manager will manage the KPI assimilation/reporting process, drive initiatives that will result in improvement of objectives.Act as Quality Management Representative for the siteBuild cross functional team collaborative cultureTrack and monitor key performance indicators, create summary reports for the site metrics, and promote improvements based on data driven decisionsProvide training to the organization regarding ISO13485 requirementsCoordinate QA improvement activities with product management, software development, test and operational support teams.Lead and participate on Practical Process Improvement teamsThe Quality Manager will support sourcing initiatives assisting with vendor management and selection.Also provide resources to verify first articles ensuring appropriate design transfer to suppliers.Requirements:Quality Management experience in a manufacturing environment preferably in medical devicesKnowledge of CAPA and understanding of risk application preferably within a medical devices environmentProblem solving and root cause analysis expertiseExperience with budgets and cost trackingQuality Systems Regulations, knowledge of ISO13485Supervisor/Management experience required, developing people and selfDesirable:Working knowledge of international regulation (with respect to instrumentation).Working knowledge of EC regulations e.g. EMC, Low Voltage, IVD Directives preferredMember of the IQA or similar organization (including a quality qualification) preferredISO13485 Lead Auditor Certification preferredIdeally Six Sigma Black Belt or with other continual improvement methodologies is preferred 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