Quality Engineer required by CareerWise Recruitment for our Biotech client in Shannon, Permanent role. The Quality Engineer is responsible for supporting the Quality Assurance Manager in the planning and execution of activities related to the maintenance and development of the Quality Management System THE ROLE: Assist in the development, implementation, and maintenance of the QMS. Follow all company policies and procedures. Perform incoming inspection and maintain component specifications. Performing sampling on finished product and authorise the release. Maintain the Approved Supplier list and related supplier documents. Maintain BOMs (Bill of material) for all manufacturing products. Perform and lead root cause investigations. Coordinate corrective/preventative action activities and completes follow up evaluation to determine the effectiveness of corrective/preventative actions. Perform and assist with Internal and External Audits. Support with customer and notified body audits. Lead risk and failure analysis (pFMEA) Ensure that customer requirements are incorporated into product functional specifications. Support with equipment and software validations. Maintain the non-conforming material reports and NCMA. Lead and participate in communication with other departments and affected personnel to problem solve or make improvements. Support in the preparation of slides for management review. Support in the management of reworks and change controls REQUIREMENTS: Degree in business, science, or engineering (or similar discipline) Minimum 2+ years working in a regulated environment e.g. ISO , GMP/GDP regulations and working with QMS. Strong interpersonal and professional skills required in the areas of verbal and written communications, customer focus, service to internal and external customers, training, influencing and team building. Proficiency in Microsoft Office applications (Word, Excel etc) Experience in quality system audit Please call James Farrar today for further information on or email: CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent. Skills: Quality Engineer