Job Description
Our client based in Sligo are currently recruiting for the position of Quality Engineer as they expand operations. Responsibilities: Provide technical quality support to Project Manager, Design Engineers, Production manager and clients. Work closely with Engineering team and the client to establish and maintain compliant product specifications. Quality review of process validation plan, protocols, and reports. Co-ordinate and contribute to the generation and maintenance of compliant product risk management files. Issue, review, and release of lot records to manufacturing. Co-ordinate and review of testing and release of sterilise product. Quality review of SOPs, Work instructions, templates, Material specifications etc. to ensure compliance to applicable regulatory standards and cGMP procedures. Review and approve product change controls. Liaise with suppliers and clients on quality related issues. Perform an active role in the maintenance, further development and continuous improvement of the QMS. Support QMS as quality coordinator in investigation, root cause analysis, disposition, and corrective action of non-conformances & customer complaints. Perform CAPA reports. Support clients in product submission to applicable regulatory authorities. Conduct internal audits and compilation of associated documentation. Support and assist in the preparation for customer and surveillance audits. Updates job knowledge by participating in educational opportunities. Requirements: Minimum Degree in a Science or Engineering discipline. 3-5 Years experience working in a medical device environment. Strong knowledge of ISO 13485, FDA regulations 21CFR 820. Strong knowledge of MDR & FDA product submission requirement. Internal/external auditing experience would be an advantage. Validation experience including Sterilization, process and packaging validations would be beneficial. Knowledge of Medical Device manufacturing environment including cGMP would be an advantage. Strong understanding of the general principles of ISO 14971. Strong decision-making ability, coupled with the ability to work on own initiative with minimum supervision and ability to multitask and prioritise is required. Demonstrate detailed working knowledge of the medical device industry. Excellent written and verbal communication skills, with the ability to communicate appropriately with different Engineering teams, Project Management, suppliers and customers. Self-motivated, flexible with a desire to learn new tasks. For more information and a confidential discussion on the role please contactMichelle Mc Inerney. Skills: Quality Operations Engineer