Quality Assurance Engineer
ICDS Recruitment
Waterford
QUALITY ASSURANCE ENGINEER. 4 Quality Assurance Engineers to work on 4 cycle shift - whose role is to ensure that the manufacturing operation produces product that meets specifications within a manufacturing environment that complies with all relevant standards. Person Specification: 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. High attention to detail. Responsiblities: 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. 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, includingapproval of validation documentation, updating PFMEAs , manage CAPA activity & continuous improvement. Act as the MQM interface with Operations and engineering functions. 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 (eg, FDA, ISO and MDD) 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 Manufacturing Quality Manager. This job originally appeared on RecruitIreland.com.
2585 days ago