Job Title: Quality EngineerDepartment: QualityStatus: Full TimeLocation: Cork, Ireland FacilityReporting To: Quality Manager, dotted line to Site LeadPosition Purpose:The Quality Engineer performs quality activities concerned with continual improvement of products, processes, and materials, by applying quality and reliability disciplines. This position follows business processes, procedures and work instructions affecting quality of the design and manufacture of products and processes. This position is responsible for assisting in development and implementation of measures, reports, and monitoring results to determine areas for improvement.Responsibilities:Ensures compliance to external and internal Quality Standards for Manufacturing and Product DevelopmentFollows policies and procedures for identifying, analyzing risk throughout the product life cycleSupport product and process risk control measures (i.e., pFMEA, dFMEA risk evaluation) and risk management files (i.e., control plans, reports, safety profiles)Assists in evaluations, tests, and decisions to maintain Quality ObjectivesFollows Quality Processes, Procedures and TechniquesAssists on actions related to Internal Non-Conformities, Manufacturing Deviations and Corrective and Preventative ActionsAssists in audits and investigations of products, services, or internal business processes to identify and correct issues causing non-compliance of product to specification, escape of non-conformances to customers or ineffectiveness of a business system to achieve its intended purposeAssists in equipment calibration and maintenance program as necessaryPerform Device History Record (DHR) review to ensure manufacturing documentation are accurate and complete as necessaryInternational site specific responsibilities:Participate in transfer, validation, and calibration processes.Controlling, updating, and retaining all quality documents, and ensuring that changes and revisions are identifiable and communicated accordingly.Comply with and strictly adhere to all requirements, tasks, and obligations derived from Harland Medical System’s Quality Management System.Comply with the Occupational Health recommendations, standards, programs, and use of personal protective equipment (PPE) established by Harland Medical Systems and report through the appropriate channels about improvements to prevent incidents or occupational diseases.Support and/or perform other duties as requiredEducation, Qualifications & Experience:Knowledge of compliance to ISO 13485: 2016 and QSR (FDA)Minimally, understand and apply knowledge of ISO 17025: 2017Ability to follow business systems, policies, procedures, work instructions, and specifications.Strong Analytical / problem solving skills with a demonstrated ability to collect, summarize and report technical information.Strong computer competency in MS Office - Word, Excel, and Outlook.Detail oriented, highly organized individualIntegrity, high ethical standardsExcellent verbal, interpersonal and written communication skillsSelf-starter, and motivated individual who works independentlyBachelor’s degree in engineering or scienceASQ CQE preferred3 – 5 years’ experience working in the medical device industryISO 13485:2016 certified preferredAuthority:Report to management on the performance of the Quality Management System, and any need for improvement.Ability to stop production line due to a non-conformance.Make quality-related decisions on the production line.Implement process improvements such as lean, etc.For Laboratory sites:Ensure the effectiveness of laboratory activities.Committed to impartiality and confidentiality, including not allowing commercial, financial, and other pressures to compromise impartiality.Working Conditions and Health & Safety:Heated and air-conditioned office environmentISO Class 7 CleanroomLaboratorySome International travel required (10-15%)Employee is required to use appropriate PPE including, but not limited to, nitrile or latex gloves, lab coat, hair bonnet, shoe covers, beard cover, safety glasses, hearing protection, face shield, or respiratory mask while working in a lab or manufacturing spaceHarland Medical System’s commitment to ensure employee health and safety is a priority. Personnel engaged in manufacturing shall obtain training required by ISO 13485, FDA 21 CFR part 820, FDA 21 CFR part 210 & 211, and Harland Medical System’s internal procedures, where deemed appropriate per assigned job functions.
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