Our client based in Galway are looking to hire a Quality Administrator as they expand operations. 4 Day Week OptionOnsite Role Permanent PositionThe Role: This position focuses on supporting and maintaining the organization's Quality Management System (QMS) and electronic QMS (eQMS). The role involves managing the SAP system, particularly in change control and quality modules, and contributing to the implementation, training, and maintenance of the Assent Portal. Additionally, the role includes responsibilities in document and record control, audits, risk management, and other QMS-related activities. As the Document Control Administrator, you will lead efforts to ensure all quality system areas are compliant.
Requirements: Support the administration and maintenance of the eQMS.Support the Quality related modules in eQMS (e.g. documentation, training, change control etc.)Act as the Quality Subject Matter Expert (SME) for eQMS within the organisation.Deliver eQMS related trainings.Support the administration and maintenance of the SAP System in terms of change control and the Quality related modules.Assist with the Assent Portal implementation and act as the Quality Subject Matter Expert (SME) for Assent within the organisation.Deliver Assent related trainings.Own and manage the various components of the current operational Quality Management System.Provide support for the Document Control and Record Control activities.Generation of reports for data trending and analysis of the quality system.Aid in generation of management review metrics as required.Knowledge and adherence to regulatory standards including ISO 13485, ISO 14971.Complete internal audits and assist in preparation for external, supplier and regulatory audits and audit follow up activities.Compliance to applicable regulatory standards and current GMP procedures and practices.Initiate and process Engineering Change Orders for document release and update.Actively participate in continuous process improvement initiatives.Escalate potential deficiencies to ensure timely resolution.Participate in training events to continuously develop and maintain competencies.Respond to non-standard requests from customers and suppliers.Support quality system compliance activities and follow up to ensure satisfactory closure of identified gaps.Qualifications: Diploma qualification in Quality or a related discipline or significant relevant experience in a quality systems role within the Medical Device Industry.Thorough knowledge of medical devices quality systems and associated regulatory requirements (ISO 13485, FDA etc.).A minimum of 3 years' experience in a similar Quality related role in the Medical Device industry.Experience working with eQMS, SAP and Assent systems a distinct advantage.Excellent attention to detail.Good communication skills both verbal and written. Fluent English skills required.Self-directed and results driven team player.Ability to work on own initiative to achieve deadlines while also capable of working as part of a multi discipline team.A positive attitude in dealing with people.Ability to learn and adapt to various situations.
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