Supplier Quality Engineer

Careerwise Recruitment

Limerick

Supplier Quality Engineer required by CareerWise Recruitment for our Limerick based medical device client. Please contact Conor Twomey on 021 4297422 / 087 0907204 for more information. The Role. The primary function of this role is to provide Quality Engineering support to the monitoring, approval and appraisal of suppliers from a quality perspective. Provide support and guidance to departments liaising with suppliers from an operations, engineering and quality control perspective. This includes, but is not limited to, providing support to process/ supplier validation, change requests, non-conforming product issues, Corrective and Preventive Action program, risk assessment and associated Quality System Documentation. Responsibilities: * Perform supplier quality audits and management of the supplier corrective action process. * Maintain and update supplier audit schedule when required. * Track supplier quality performance measurements for suppliers (KPI's) and participate in supplier performance reviews. * Completion and approval of supplier evaluations and monitoring when required. * Manage and drive continuous improvement activities focusing on supplier quality. * Review and support Supplier Change Notifications. * Review and approval of raw materials, first part approval and supplier process validations. * Maintaining supplier quality documentation in conjunction with purchasing. * Completion of risk assessment of suppliers, non-conforming materials and CAPA's. Requirements. * Third Level qualification in Science, Engineering or a relevant technical discipline. * Qualification in Quality/Validation/Statistics would be a distinct advantage. * Proven knowledge and experience (ideally minimum 4 years) of working with ISO13485, ISO14971, the Medical Device Directive and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11, ideally gained in the medical device industry. * Qualified Lead Auditor, preferably within the Medical Device Industry desirable. * Proven knowledge and experience of all aspects of Validation including Process Validation and design validation. * Good working knowledge of statistics. * The ability to challenge thinking/opinion/actions in light of ensuring Quality Systems and Processes are adhered to. * High attention to detail in all aspects of the role. * Good working knowledge of Microsoft Office. CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives absolute assurance that this wish will be respected at all times. For further information please contact Conor Twomey on 021 4297422 / 087 0907204. Or apply online via; www.careerwise.ie. In search of excellence. Specialists in the recruitment of. Senior Management, Commercial, Technical/Engineering, Commodity Managers, Senior Supply Chain & IT Personnel, Automation Engineers & Strategic Procurement Specialists. Supporting Business Demands & Growth since 1999. This job originally appeared on RecruitIreland.com.

2821 days ago