For our client, a leading global medical device manufacturer, we are seeking a Lead Quality Engineer to join a dynamic New Product Development site in Galway, Ireland. The role is hands-on, the only one in Quality, with end-to-end responsibilities for quality, including training and development of production staff. This is a unique opportunity to play a pivotal role in the development and production of innovative medical devices.This is a multi-functional, hands-on role, ideal for someone who thrives in a dynamic environment where responsibilities span across the Quality Management System (QMS), elements of Quality Control (QC), and cross-functional engineering support. Given the lean nature of the site, the successful candidate will be a key contributor across various quality and operational areas.Please note that the role requires daily on-site presence.Key Responsibilities:Oversee and support daily quality activities on the production floorMaintain and improve the Quality Management System (QMS) in line with ISO 13485Conduct internal audits and identify areas for improvementLead investigations, root cause analysis, and implement CAPAsReview and approve DHRs, validation protocols, and change controlsSupport risk assessments and product risk management activitiesManage supplier quality and conduct supplier auditsTrain and support teams on quality standards and best practicesMonitor key quality metrics and report performanceEnsure quality is integrated throughout product developmentSupport audit readiness and regulatory inspectionsRequirements:Proven experience in quality engineering in a medical device manufacturing environmentExperience working with Quality Management Systems (QMS) and standards such as ISO 13485 and FDA regulationsStrong understanding of quality control principles, statistical analysis, and root cause analysis techniquesExperience with internal and external auditsExperience working in small or fast-paced environmentsStrong hands-on experience with V&VAbility to work independently and take ownership of quality processesSkilled in coaching and guiding production teamsExcellent documentation and communication skillsFlexible, hands-on, practical, and comfortable with cross-functional tasks
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