Cache of job #14092069

Job Title

SterilISAtion/Quality Engineer






A Sterilisation/Quality Engineer is required by CareerWise Recruitment for our Roscommon based client. Reporting to the Quality Engineering Manager, the Sterilisation/Quality Engineer will provide ongoing support to the manufacturing team in an effort to maximise production quality performance, including identifying root cause, implementing corrective/preventive action on all quality issues in production. Scope of role will also include addressing any customer related issues identified in the manufacturing process and validation of new processes/products. Please contact Tom Devaney for more information. THE ROLE: * Review, update, maintain and improve existing quality management processes and procedures. * Ensure quality standards are adhered to, and all production processes are carried out according to procedures. * Raise quality profile and operating standards within the business. * Initiate and drive continuous improvement programs. * Ensure that the company retains ISO accreditation. * Site SME for all sterilisation activities, providing technical excellence in the field of gamma and ethylene oxide sterilisation methods. * Lead sterilisation validation for new products and change control. * Maintain sterilisation programs (evaluation of changes, EO requalification. * Ensuring compliance to all relevant regulations for sterilisation and microbiology which includes maintaining all quality systems and related documentation. * Maintain detailed and accurate quality records, data analysis and documentation. * Non-conforming material investigation, customer complaints, CAPA investigation, analysis and improvement. * Data analysis and trending, statistical process control, root cause analysis and the implementation of corrective actions. * Ensure quality inspection instruments are accurate and regularly calibrated, tested and audited, * Prepare and execute process/product validations. * Ensure new product introductions and change controls are effectively managed in accordance with the ISO requirements when appropriate. * Supporting the introduction of new product lines through development of product inspection plans, process FMEAs and risk management plans. Conduct internal audits. * Host audits of the company's operations by external bodies (e.g. audits from customers, audits relating to certification to official standard e.g. ISO 13458. * Conform to the requirements of the quality and environmental management systems. REQUIREMENTS: * A Degree in Quality Assurance or equivalent. * Minimum of 5 years experience in a Quality Engineering / Sterilisation / Microbiology role, preferably in the Medical Device sector. Please call Tom Devaney today for further information on 091-758771 or email: CareerWise Recruitment (In Search of Excellence. Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the Medical Devices, Pharmaceuticals, 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.

Date Added

187 days ago