Quality Assurance Director - Medical Devices - West Midlands

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A highly exciting opportunity has arisen for a Quality Assurance Director to work at a Medical Device Manufacturer that manufactures over 2000 products. The successful Quality Assurance Director will provide leadership, experience, direction and guidance to the UK facility. This position will plan, develop and control in conjunction with the companies QMS to ensure that all the quality objectives are met. This position will be responsible for providing support and communication with the manufacturers operations groups and clients to address design, manufacturing and other problems related to product issues. The successful candidate will require 5-7 years of experience in Quality Management within a Medical Device Manufacturer. A High degree of knowledges of FDA and EU medical device regulation.Primary Duties/ResponsibilitiesManagement Representative of the UK siteAssures that all local, national and international standards and regulations are effectively implementedAssures the effective implementation of the QMSAddress customer quality issues and internally improve cost and competencies in process control/ validation studies, root cause analysis, failure mode and effect analysis (FMEA), and the use of process excellence tools.Manage training, document controls, internal audit and other required quality processesMaintain and control plant quality proceduresPromote/execute continuous improvement and excellence activities for transactional Quality Processes and manufacturing processesDevelop and implement risk management methodologiesProduce advanced quality planning documentation where applicableActively manage all the goals and objectives defined in the QMSResponsible for the maintenance of technical filesReview and approve the validation of new/changes in production processes as necessaryDesign and validation of the processes of the Quality System where applicableParticipate in the design evaluations where applicableSolve quality problems and eliminate restrictions to ensure that project objectives are metManage local supplier quality management and sterilization to improve the quality through a review of prequalification, supervision and continuous audit, implementation of engineering changes, validation, product qualification and processes and other procedures and instructions.Analyses QMS and manufacturing processes using valid statistical methods to assess trends and to assist the administration. In the identification and resolution of problems and the effort to improve overall quality.Ensure effective implementation of the CAPA; develop and implement initiatives to improve proactive processesGenerate quality metrics and establish the measurements to monitor quality costs and cost reductionEnsure the effective handling of customer complaintsMaintain the GMP requirements, including environmental and personnel controlsEnsure that all health safety and environmental requirements are metMaintain detailed and accurate records of all activitiesResponsible for the maintenance of metrics to monitor the general performance of the departmentManage external audits by Regulatory Bodies and customersPrepare Management ReviewAssure appropriate organization and resources to execute quality-related processesThis is a brilliant opportunity to further your career, if you feel you have the suitable skills and experience, and are a UK based citizen, then please apply and I will be in touch! 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