Job Description
Quality Engineer - County Sligo. Key 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 sterilised product. Quality review of SOPs, Work instructions, templates, material specifications etc. to ensure compliance with 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. Update job knowledge by participating in educational opportunities. Interested applicants should have: Minimum Degree in a Science or Engineering discipline. At least 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 sterilisation, 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. 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. Excellent attention to detail with strong numerical and problem-solving ability, while maintaining awareness of longer-term objectives. Excellent MS Office experience (Word, Excel, PowerPoint etc.). Skills: Quality Engineer Medical Pharma