Quality Manager Medical Devices Waterford

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Role: Quality ManagerLocation: WaterfordIndustry: Medical Devices A client of ours in Waterford are expanding their quality team and one of their priority roles is or a Quality Manager. Reporting into the General Manager and looking after a team of 15 quality staff your role will include the following: responsibilities: Remain up to date with ISO requirements and ensure the company is audit-ready.Plan and monitor internal audit schedule.Quality system development, implementation & maintenance.Ensuring that processes meet with ISO and AS requirements.Assessing product specifications and customer requirements and ensuring they are met.Agreeing in-house standards for quality.Monitoring performance by gathering data and producing reports.Supervising the programme of internal auditing and calibration.Development, Maintenance, and Approval of Standards.Managing quality issues to ensure timely and effective corrective actions to prevent re-occurrence.Providing support to Regulatory and Customer audits.Monitoring the ongoing performance and outputs of the quality process and providing updates to managers and directors around quality issues.Supplier and Customer Liaison on Quality Issues.Provide validation expertise to maintain validated status for the facility.Oversee the design and execution of commissioning and validation protocols on manufacturing equipment, software, and process, and approve validation documentation.Maintain an understanding of cGMP regulations and guidance in relation to all aspects of qualification of process and equipment.Coordinate validation activities to ensure schedule adherence and compliance.Using statistical analysis, measure, control, and improve product and process robustness. Experience and Knowledge:Postgraduate degree in a technical or regularity discipline desirable.3rd level Qualification in Scientific/technical discipline.Ability to introduce and embed new systems successfully.Thorough understanding of ISO 13485.10 + quality experience in manufacturing.Experience in subcontract manufacturing with numerous product lines.Experience in Quality management, including quality systems management.Experience leading and developing teams.Experience with FDA regulations desirable. 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