Our Client, a leading medical device manufacturer in Galway is hiring a Document Control Administrator.
Responsibilities include but are not limited to the following:
- 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 organization.
- 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 organization.
- 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.
- To take on other duties which the Company may assign you from time to time. These ‘other duties’ will be agreed with Management prior to any assignment.
