Job Description
An exciting opportunity has arisen for a site quality lead to join a new expanding medical device facility in Dublin. This is an opportune time to join as the company goes through a period of growth. The quality lead will act as a technical expert in equipment validation, driving investigations and leading a team within a laboratory environment. Responsibilities will include: Identifies and evaluates new and/or equipment improvements. Responsible for purchasing, installation and validation of equipment. Serves as technical expert regarding general laboratory instrumentation, equipment, and processes. Manages and maintains on-time calibration and preventive maintenance of laboratory equipment. Communicates with suppliers to drive on-time completion of activities. Drives investigation activities for out of specification (OOS) calibration results. Supports test method and fixture development, as needed. Manages inventory and related documentation including, but not limited to, laboratory supplies, test samples, and chemicals. Identifies and implements continuous process improvements in the laboratories, as well as, contributing to lab network initiatives. Supports audits (regulatory, customer, internal) as a subject matter expert. Performs internal audits and compliance assessments, when needed. Leads change management activities for lab processes. Supervises technicians performing complaints and/or release activities. Conducts on-boarding and ongoing training program of lab associates. Manages 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 Performs 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. Requirements: Bachelor degree in Engineering, Science, or other related discipline. Up to 5 years experience in a similar role is required, or equivalent: 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 Education 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 Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative. BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES. Skills: Quality Compliance Validation Equipment Qualification