Quality Engineering Manager

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Duties:Establish and develop quality systems, procedures and policies in line with corporate and customer requirements.Lead continuous improvement initiatives to challenge the quality systems processes with respect to compliance / value add.Responsible for leading and developing a dedicated team of professionals in order to support the compliant operations within the associated business unit.Interface with customers to ensure concerns/complaints are communicated and effective corrective and preventive actions are implemented in a timely manner.Monthly and quarterly reporting of Quality Key Performance Indicators (KPI's) both internally and to corporate including the coordination of necessary activities to drive improvements or address adverse trends.Drive the achievement of our set targets as specified for continuous improvement.Lead and manage risk assessments across the business to drive quality improvements.Drive improvements via data analysis on product and process and drive best practice across the businessPlay a key part in transfer projects to ensure flawless transition into OperationsProvide critical support to the business units with regard to vendor qualifications / corrective & preventative actions.Develop and sustain the drive towards a business unit culture of audit readiness.Play an integral role in planning and managing all activities with respect to quality audits / visits.Execution of Validation Master Plans (VMP) with follow through to Validation Summary Reports. This will also include the sign-off on validation documentation for operational validation activities.Batch paperwork review and final decision to release product for shipmentDrive and embed and preventive action culture via root cause investigation and collaboration with Operation's.Interface with other sites with respect to sharing of best practices.Compliance to all site Environmental, Health and Safety requirements, training and regulations & all local site company policies, procedures and corporate policies.Perform additional duties at the request of the direct supervisor.Lead and manage a high performing team to deliver the defined business goals & objectives.Identification and development of talent to include performance management and succession planningCoaching / development of the employees using development and retention plans as appropriate.Requirements:Must have a third level qualification in Engineering/Quality/Science.Must have a thorough understanding of Quality Systems / CFR's eg. ISO 9001 / ISO 13485 / ISO 14001, 21 CFR Part 21 / 820.Must have a thorough understanding of statistics, SPC, and preferably DOE/Windows studies.Must have a minimum off 7 years quality management experience preferably in a high volume FDA regulated environment.Must be able to work in a team environment, prioritise and organise tasks, with excellent communication skills both oral and written.Ideally will have experience of Medical Device development form concept to market launch, 6 Sigma certified "Greenbelt", injection moulding / high speed automation experience. *Please Note: Applicants are required to have Stamp 4 Visa/Full EU Working Rights as sponsorship is not provided for this role.* 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