JO-2410-542369 Our client - a leading global medical technology company, requires an experienced Laboratory Lead for their new R&D facility in South Dublin. The successful candidate will support the start-up and implementation of the Quality laboratory and the qualification of lab equipment, processes, and/or test methods related to product release and complaints testing.
RoleQuality Laboratory Leader: You will set priorities for the Quality Lab and be accountable for the success of all deliverables, while ensuring related operations.Support start-up and implementation of the Quality laboratory and the qualification of lab equipment, processes, and/or test methods related to product release and complaints testing. Activities include, but are not limited to, identification of product defects and potential issues, data analysis, and trending.Responsible for final batch release and complaints processes for commercial product, including the management of any associated outsourced activities.Supports the continuous improvement of testing and/or quality assurance processes, provides technical support on equipment and methods, and is responsible for proactively managing complex issues with a high level of autonomy.Supervises technicians performing complaints and/or release activities.Conducts onboarding and ongoing training program of lab associates.Maintains good laboratory practices (GLP) consistent with corporate and regulatory guidelines.Maintains good documentation practices (GDP) when generating test data and records in accordance with ISO, cGMP and other applicable regulations and standards.Complaints ManagementManages and drives completion of commercial product complaints activities: planning, sample management, investigations, reporting, oversight of activities performed by support team(s) and/or supplier(s).Performs complaint Quality Data Analysis, as needed. Identifies and reports trends and/or triggers for significant complaint issues.Product ReleasePerforms final product release operations. Maintains documentation, reviews inspection results, and dispositions product.Initiates or performs non-conformance investigations, if needed.Trends incoming inspection data, as needed.Identifies and reports trends and/or triggers for initiating supplier complaints.RequirementsBachelor's degree in Engineering, Science, or other related discipline.Minimum 5 years relevant experience: Pharmaceutical, medical device, diagnostics, or Quality Control.Knowledge of the operation of mechanical measurement and testing equipment (e.g. Instron) and CT scanners.Understanding of industry standards and regulations such as ISO, FDA, OSHA, ASTM.General knowledge of problem-solving and root cause analysis methodology.General knowledge of statistical techniques.DesirableEducation or experience related to electromechanics and/or electromechanical devices highly desirable.Ability to troubleshoot electromechanical devices and software highly desirable.Experience with equipment qualification desirable.Experience with computer system validation desirable.
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