Quality Systems Engineer

CPL

Galway

On behalf of my client, a reputable medical device company in the Galway area, I am recruiting for a Quality Systems Engineer to join their team. You will work within the QA Department and take day to day responsibility for the running of QA based systems including document control, running of NCR and CAPA systems, internal auditing process and other systems. You will also take a lead role in supplier management and will be the point of contact for the incoming inspection process. Responsibilities: Identify and implement effective process control systems to support the continuous improvement of the quality systems as a whole. Oversee QA office systems and functions. Involvement in incoming inspection and supplier management. Develop and implement quality metrics and reporting systems. Support and deliver continuous improvements and to employ problem solving tools including root cause analysis and CAPA identification. Preparation of Quality reports for Quality meetings and management reviews. Take a lead in the implementation of process controls and CAPA systems designed to meet or exceed internal and external requirements. Ensure regulatory compliance to GMP for all medical device regulatory agencies. Suggest changes in procedures and standards to facilitate work efficiency and maintain quality. Conduct internal quality audits to ISO13485 and GMP requirements. Report on KPIs in order to adhere to process and prevent occurrence of any non-conformity relating to product, process or systems. Take part in third part audits as required. Qualifications & Experience: Science / Engineering / Quality Degree and relevant Quality experience. Previous experience within the medical device industry in Quality / Engineering is essential. Good working knowledge of ISO13485 systems. Knowledge and experience of Statistical Process Control would be beneficial. Flexible, highly motivated individual and accountable. If you are interested in applying for this role please call Nicola on +353 1 2784671 or email ndunphy@thornshaw.com. Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com. This job originally appeared on RecruitIreland.com.

2165 days ago