Quality Shift Engineer Waterford
FRS Recruitment
Waterford
Are you looking for an opportunity to join a world renowned Medical Device organization in Waterford as a Quality Shift Engineer ? Permanent position with excellent career development opportunities! Would you like to work within a company where the work you do will help make a major difference in peoples lives? This is a company where you will gain incredible experience in a rewarding work environment. Reporting to : Manufacturing Quality Manager. Key Responsibilities: 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, including approval 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 FMEAs. Participate in Quality System Continuous Improvement activities. Ensure regulatory compliance to GMPs of applicable medical device regulatory agencies (e.g, FDA, ISO and MDD) and internal documentation. Provide direction to ensure product quality is maintained at all stages of the manufacturing operation. Requirements: Third level Qualification in Science or Engineering. Minimum 3 years in a similar role within a regulated pharmaceutical/medical device environment. Manufacturing quality experience. 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. 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. If you think this could be the perfect match for your next role, APPLY TODAY! This job originally appeared on RecruitIreland.com.
1801 days ago