Laboratory Quality Manager

at  Beacon Hospital

QUALIFICATIONS

• MSc in Medical Laboratory Sciences or equivalent Quality Management qualification
• Evidence of ongoing CPD
• Management or supervisory training
• Training qualification

EXPERIENCE

• At least 7 years post graduate experience working in an accredited laboratory, at least 2 years of which were at a supervisory level,
• Experience of ISO15189 accreditation for laboratories
• Quality management
• Q-Pulse

SKILLS & ABILITIES

• Co-ordinate with laboratory management and other hospital departments to ensure delivery of a quality laboratory service
• Demonstrate the capacity to lead the quality process of the laboratory team.
• Excellent interpersonal and communication skills and a professional and dedicated attitude.

KNOWLEDGE & UNDERSTANDING

• Appreciation of all aspects of the provision of a QMS in the laboratory service.
• Be familiar with accreditation criteria and objectives.
• Be familiar with legislation as it pertains to the provision of a quality laboratory service.
• Demonstrate the capacity to be part of a team and to manage staff.
• Be familiar with IT packages supporting office and laboratory service including Laboratory Information Systems.
• Be familiar with other hospital departments and their relationships with the laboratory.
• Be familiar with current health and safety legislation as it pertains to the laboratory.

OVERALL PURPOSE OF ROLE

The development, implementation and maintenance of a compliant, efficient and functional Quality Management System (QMS) for all laboratory departments in line with ISO15189 standards, AML-BB and EU Directives.
These areas comprise: Blood Transfusion and Haemovigilance, Haematology, Biochemistry, Microbiology, Histology and Near Patient Testing. This position requires familiarity with the area of work, relevant statutory requirements, the clinical governance, risk management, quality audit policies and procedures of a hospital setting and the systems of accreditation in use.

RESPONSIBILITIES AND DELIVERABLES

• Have interpersonal and communication skills and a high capacity for professional responsibility and individual initiative.
• Have in depth knowledge of the relevant regulation and underlying quality procedures necessary to support the needs of the laboratory.
• Provide support, advice and leadership on all quality related matters across the range of functional areas with the laboratory and associated areas.
• Remain 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.
• Have familiarity with the quality standards required by GLP, GMP, JCI, ISO15189, EU Directive 2002/98/EC, EU Directive 2004/23/EC and the requirements of the HPRA and any other relevant legislation.
• Ensure that the QMS is developed, established, implemented and maintained on behalf of the Laboratory Management.
• Ensure that internal and external quality control measures are performed, reviewed and assessed at quality assurance meetings.
• In conjunction with Laboratory Management, to develop, implement and manage a system for continuous service improvement. Identifying areas and particular projects where there is the potential for improvement of quality, investigating audits, service complaints/incidents and ensuring effective and timely follow up actions are taken.
• Establish structured systems for the used of audit as an impartial tool to monitor performance and compliance within the laboratory.
• Manage both internal and external audits and inspections in terms of preparation for such events and implementation of findings within an appropriate timeframe.
• Ensure that there is a functional document control system and compliance with maintenance of the master document index. Ensuring that all documents and forms are retained for reference and inspection for the designated periods and are readily available when required.
• Manage and participate in the writing, reviewing and updating of all procedures and documentation relating to the laboratory.
• Training of all staff in all aspects of the QMS.
• Ensure that all critical equipment used in the laboratory is under a routine verification, calibration and planned preventative maintenance programme.
• Manage all non-compliance, out of specification or deviations from protocol and the implementation and maintenance of a system to document and evaluate such events.
• Collect, analyse, interpret and present quality data and statistics relating to the laboratory and associated areas as appropriate and as required.
• Bring to the attention of Laboratory and/ Hospital Management any information or findings that could adversely affect the quality of the service provided by the laboratory or associated areas.
• Attend and actively participate in committees and meetings as requested by Laboratory or Hospital Management.
• Foster a culture of openness, compliance, initiative and best practice amongst staff within the laboratory and associated areas and maintain good working relationships with all clinical, nursing and scientific staff.
• Completion of any other duties as requested from time to time by Laboratory or Hospital Management that might reasonably be expected to form part of the role of the Quality Manager.