QUALIFICATIONS

Essential:
Possess a degree in Biomedical Science or relevant field

OVERALL PURPOSE OF ROLE

The continual improvement and maintenance of a compliant, efficient, and functional Quality Management System (QMS) for all laboratory departments in line with INAB regulations, ISO 15189 standards, AML-BB and EU Directives, and JCI.
These areas comprise: Blood Transfusion, Haematology, Biochemistry, Microbiology, Histology, Point of Care, and Haemovigilance.
This role requires familiarity with the area of work, relevant statutory requirements and quality audit policies and procedures of accreditation in use.

RESPONSIBILITIES AND DELIVERABLES

To be professionally responsible for all aspects of the post holders own work.
To be responsible for ensuring that the post holder remains up to date with knowledge and understanding of all new quality developments in the Laboratory and associated areas and to actively promote and participate in continuing education in these fields.
To be familiar with the quality standards and relevant regulations required by a medical laboratory in a hospital setting.
To ensure the QMS is current and maintained on behalf of Laboratory Management.
To ensure that the QMS complies with the requirements of JCI, ISO 15189, EU Directive 2002/98/EC, EU Directive 2004/23/EC and the requirements of the HPRA.
To assess departmental compliance with meeting performance indicators and address matters arising at quality assurance meetings.
In conjunction with the Laboratory Management, support continuous service improvement. Identifying areas and particular projects where there is the potential for improvement of quality, investigating audits, service complaints and incidents and ensuring that effective immediate and follow up actions are taken.
To support the management of both internal and external audits and inspections in terms of preparation for such events and implementation of findings within an appropriate time frame. To partake in scheduled audits as required.
To ensure that the document control system is current, compliant and maintained. To ensure appropriate retention of documents and forms for reference and inspection for the designated periods and are readily available when required. To ensure that policies and procedures have been distributed and acknowledged.
To manage and participate in the process of writing, reviewing and updating of Quality procedures and documentation relating to laboratory activities and associated areas.
To assist in the training of staff in all aspects of the QMS.
To assess compliance of critical equipment used in the Laboratory to meet routine verification, calibration and planned preventative maintenance programmes. Maintain and update the assets register as required.
To support the management and evaluation of non-compliance events, non-confirming works and laboratory related patient safety events.
To collect, analyse and interpret and present quality data and statistics relating to the Laboratory and associated areas as appropriate and as required. Support the completion of the annual quality management review for laboratory activities.
To bring to the attention of the Laboratory and Hospital Management any information or findings that could adversely affect the quality of the service provided by the Laboratory and associated areas.
To attend and actively participate in committees and meetings as requested.
To foster a culture of openness, compliance and initiative and best practice amongst staff working in or liaising with the Laboratory and associated areas. To maintain good working relationships with all clinical, nursing and scientific staff.