Quality Manager

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Our client is a well known manufacturer of medical device products sole all around the world specialising in optics and medical devices.They are currently looking for a Quality Manager to join the team during a period of rapid growth.Role Summary:Manage and oversee all Quality Assurance functions and staff within the including Management responsibility, Design controls, Production and process control, Microbiology and CAPA. Application and execution of appropriate governance and reporting models to ensure efficient running of the department in order to match financial, production and business requirements.The Quality Manager will drive continual improvement within the function and peer functions, ensuring an efficient Quality System is established to support the strategic needs of the business and ensure ongoing compliance to all appropriate regulatory and company requirements.The Quality Manager will be the Management representative for the facility. Will be ongoing promotion and development of all GMP/cGMP activities across the facility and facility management, including critical process monitoring and deviation management.The Quality Manager will have overall responsibility for Management Review, CAPA, Internal Audit, Material release, Non-conforming product and material control and disposition, Microbiological and chemistry deviation management, customer complaints, Calibration and validation.Establish core KPIs to drive ongoing performance and timeliness of execution such as CAPA, Internal audit, Calibration, training and deviation management.Report ongoing performance to the business, ensuring priority deficiencies are reported in a timely fashion.Preparation and management of departmental budgetsEnsure that all appropriate engineering and improvement projects have the necessary QA support and remain compliant with all current aspects of GMP/cGMP and change management.Control investigation into customer complaints ensuring reports are compiled and issued in a timely mannerReview outgoing quality performance, ensuring deficiencies and solutions are identified and managed in a timely fashion to ensure ongoing risk mitigation.Review validation plans, protocols and reports as necessaryReview manufacturing changes and deviationsKnowledge, SkillsLeadership, motivation and management including succession planningCommunication and upward managementPrioritisation and executionResource management and balancingFunctional line of sight and alignment Functional skills and experienceBroad Problem Solving methodology and tool useProcess validationSterile and Aseptic processingCAPARisk management and design transfer including PFMEA Broad regulatory experience including FDA inspectionAbility to read and author technical documentation 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