Quality Engineer Leading Medical Device Company in Sligo Excellent career progression opportunities along with a generous package. Oradeo Recruitment is presently seeking interest for a Quality Engineer in our client's Division located in Sligo. This position comes with an excellent remuneration package and a clear path for career growth.
Duties and Responsibilities: Provide technical quality support to Project Manager, Design Engineers, Production Manager, and clients. Work closely with the 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 testing and release of sterilized products. 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 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. Support the Quality Department in implementing and maintaining QMS. Conduct internal audits and compile associated documentation. Support and assist in the preparation for customer and surveillance audits. Update job knowledge by participating in educational opportunities. Other such duties as may be assigned from time to time by their manager. Minimum requirements related to the position: 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 requirements. 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 prioritize 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. Excellent attention to detail with strong numerical and problem-solving ability while maintaining awareness of longer-term objectives. Capacity to maintain the highest level of confidentiality internally and externally. Excellent MS Office experience (Word, Excel, PowerPoint, etc.). High level of teamwork and engagement.
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