Quality Assurance Engineer
ICDS Recruitment
Waterford
Quality Assurance Engineer - Waterford. In this role you will work on either a 3-cycle or 4-cycle shift basis, ensuring that the manufacturing operation produces product that meets specifications within a manufacturing environment that complies with all relevant standards. Key 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, including approval of validation documentation, updating PFMEAs, manage CAPA activity & continuous improvement. • Act as the 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 (e.g. FDA, ISO and MDD) and internal documentation. • Provide direction to ensure product quality is maintained at all stages of the manufacturing operation. 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. This job originally appeared on RecruitIreland.com.
2523 days ago