Quality Engineer
Fastnet The Talent Group
Kildare
Quality Engineer. The Role: Liaise with shift management to manage the Manufacturing operation to provide the required volume output per shift which complies with all quality and regulatory requirements. Responsible for ensuring all testing/study activities are planned and all requirements are in place to support the activity. Determine appropriate lot disposition decisions on a shift by shift basis. Manage, review & approve any non-conformances that may occur. Provide quality oversight for manufacturing, including compiling and approval of validation documentation, updating PFMEAs, manage CAPA activity & continuous improvement. Disposition product as appropriate & manage any non-conformance activity. Highlight relevant issues and participate / lead resolution. Understand and review Validation documentation, Change Requests, Design and Process FMEA's. Participate in Quality System Continuous Improvement activities. Ensure regulatory compliance to GMP's of applicable medical device regulatory agencies and internal documentation. Provide direction to ensure product quality is maintained at all stages of the manufacturing operation. Additional requirements of the job will be specified by the Quality Manager. The Person: Minimum 3 years' experience in a regulated pharmaceutical/medical device environment. Manufacturing quality experience desirable. Full understanding of the requirements of the Regulatory Standards. Experience in Quality auditing an advantage. Experience in using Microsoft Office products. Experience of working in a team environment. Third level Qualification in Science or Engineering. Statistics/Six Sigma qualification an advantage. Good communication skills. The ability to motivate and influence people. Self-starter, highly motivated with the ability to prioritize. Strong attention to detail. Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent. Fastnet - The Talent Group. 'Not Just Placers.........Partners' The Life Science Specialists. This job originally appeared on RecruitIreland.com.
2555 days ago