Senior Quality Engineer

1 day ago

Galway, Ireland Ics Medical Devices Full time

Job Title:Snr Quality EngineerRoles & Responsibilities:· Drive compliance and achieve companies' quality objectives· Support implementation of NPI processes and systems, enhancing quality and efficiency to drive continuous improvement to consistently deliver safe and effective product· Implement and maintain Lean Product Development process· Support the development of test strategies and methods, complete protocols, testing and reports supporting design, V&V (including Sterilisation Validation, Packaging Validation, Biocompatibility and Process Validations)· Support quality system including management review process· Support design control, change control, CAPA, risk management and document control systems· Maintain an effective QMS that complies with the appropriate ISO and FDA standards and requirements· Work closely with project management and customers to deliver projects successfully meet or exceed customer expectations· Support, develop and mentor engineers and technicians.Assign tasks, coordinate, provide instruction and feedback as required· Support Customer and Regulatory surveillance and certification auditsSupport Internal and supplier auditsRequirements:· Primary degree qualification in a science, engineering or other technical discipline.· Minimum 5+ years' experience in Medical Device industry.· Experience in establishing and maintaining all aspects of QMS· Cleanroom management and validation, sterilization validations an advantage.· Experience working, building and leading effective teams.· Effective communication with senior management and working with peer leadership teams.· Customer and audit facing experience in projects and manufacturing product release is a significant advantage.· Agile, flexible, innovative and strong problem solving skills.· Experience in NPI processes and systems an advantage.Experience in CAPA, risk management and document control systems required.Job Type: Full-timeBenefits:Bike to work schemeCompany eventsCompany pensionEmployee assistance programOn-site parkingPrivate medical insuranceSick payWork Location: In person

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