Quality Engineer

Hrm

Westmeath

Our client a global leader in Medical Device manufacturing, based in the Midlands who employ highly experienced individuals focused on maximising the quality of their customers and meeting the needs of patients worldwide, are seeking a strong Quality Engineer to join their on-site team for 18 months. This organisation has ongoing development, improvement and innovation happening on-site and they are currently undergoing some exciting new projects. The Role: As the Quality Engineer, you will become a key member of the Quality Compliance Team at the organisations site in the Midlands for 18 months, due to project needs. This role requires a driven Quality Engineer and the primary purpose of this role is to plan and manage the compliance of an exciting project on site. Key responsibilities include: Plan and execute validation IQ, OQ & PQ protocols and reports to FDA requirements. Co-ordinate the completion of risk management, process capability, and statistical assessments and provide quality engineering support to resolve process problems. Write, review and update compliance documents, procedures, protocols, reports and relevant documents required in the course of achieving Quality compliance. Develop and maintain a deep understanding of processes and products within areas of responsibility in order to support process improvements, changes and projects. Support non-conforming investigations using robust root-cause analyses tools. Liaise with cross-functional teams, utilising influencing skills where appropriate, to achieve assignments on time. Establish and develop strong and effective working relationships at all levels to ensure maximum effectiveness. The Person: Minimum qualification to a third level degree in a relevant Quality/Engineering/Science related discipline and preferably with 4-6 years relevant experience in medical devices or a similar regulated environment. You are a results driven and a dynamic team player and can work effectively and proactively on cross-functional teams. You are knowledgeable about Quality Systems, validation standards, policies, procedures and methodologies. Knowledge, understanding and implementation of GAMP5 is an advantage. You are experienced with practical working knowledge of statistical data analysis and quality improvement tools and techniques. To discover more about this opportunity, apply now or contact Orla Boyle at HRM on 353 91 782110 for a confidential discussion. This job originally appeared on RecruitIreland.com.

2130 days ago