Purpose:

 The quality officer is responsible for implementing the quality programs throughout the department. S/He must work with the hospital quality department to understand the impact of the institution’s quality program and implement it in the Laboratory Department. S/He is in charge of ensuring that the results are of the highest quality and create systems to monitor data quality and performance. S/He also confirms that procedures and processes adhere to safety and compliance rules and regulations. The quality officer will conduct audits in a timely manner, reviewing policies and procedures to find the root cause of any non-conformance. The laboratory quality officer also participates in ensuring that all employees receive proper training, orientation and competency assessment. S/He may also work with the procurement department, to verify that the goods and services meet acceptable laboratory standards.

MAIN DUTIES AND RESPONSIBILITIES

• Prepare an annual budget plan to run the laboratory quality programs i.e. ISO 15189.
• Advice the laboratory director or designee on quality programs and issues related to it.
• Maintain communication with accrediting and regulatory bodies.
• Ensure laboratory activities comply with ISO 15189:2022
• Ensure continuous training and awareness on ISO 15189:2022 requirements.
• Ensure all policy documents are current and implemented as written
• Ensure that staff are trained and deemed competent with approved and current policy documents.
• Ensure mandatory documents and records including patient material are retained in accordance with approved policy documents
• Ensure effective continuous medical education programs are implemented in each section
• Ensure deficiencies raised by external auditors are closed within the stipulated timelines.
• Incorporate SAFE CARE requirements to the laboratory processes.
• Advice the laboratory director or designee on POCT programs and issues related to it.
• Develop a POCT program in accordance with accrediting and regulatory bodies.
• Support the POCT committee chair in implementing the POCT program
• Implement and continuously monitor the POCT program.
• Ensure POCT equipment are calibrated and QC run as required.
• Ensure performance and documentation of routine and preventative maintenance of POCT equipment.
• Troubleshoots and reports instrument malfunctions to supplier
• Ensure POCT equipment have documented work instructions
• Organize, plan and lead ISO15189 audits in the Laboratory department.
• Support the department in the running of the Departmental Quality Improvement and Patient Safety committee (DQIPS)
• Through the institutions Head of clinical service, develop the annual Department Quality Plan
• Oversee the process of validation and/or performance verification of existing and/or new tests, instruments and methods of equipment, tests and methods in the department.
• Prepare monthly Quality Variance Reports and present to the DQIPS and the laboratory director or designee.
• Ensure process control checks (EQA, IQC) are implemented.
• Ensure pre-analytical, analytical and post-analytical aspects of the laboratory comply with approved policies.
• Ensure equipment including reagents and other laboratory supplies are used and maintained in accordance with manufacturer’s instructions or approved policy documents
• Ensure complaints, incidents, and sentinel events are captured, investigated and resolved.
• Perform regular (at least annual) internal audits.
• Plan annual Management Review Meeting, communicate to the staff the outcome of the meeting and make follow-up to ensure that tasks identified in the meeting are addressed.
• Ensure opportunities for improvement are identified and implemented.
• Ensure each section have quality indicators to monitor performance
• Capture complaints, follow-up for closure, communicate with the affected clients.
• Ensure all occurrences are captured, investigated and resolved
• Ensure root cause analysis is done to prevent re-occurrence of occurrences
• Ensure preventive action is implemented to prevent potential occurrences
• Ensure each section participate in quality improvement activities continuously
• Ensure each section set goals and objectives every year and work to achieve them.
• Participating in the Facility Management and Safety (FMS) program
• Implement safety standards and policies with the coordination of laboratory safety committee.
• Monitor the implementation of safety program in the department
• Perform other duties as may be assigned from time to time by the laboratory director or designee.

KEY QUALIFICATIONS AND EXPERIENCE

• BSc or Higher national Diploma in Medical Laboratory Technology with 5 years’ work experience.
• Registered by KMLTTB with a valid practicing license. Minimum 3 years’ experience in leading quality management systems in the healthcare industry, specifically medical laboratories.
• Minimum 3 years in quality system maintenance.
• Excellent computer skills (Including, but not limited to: Windows, Office, Visio, Project Manager, and Internet).
• Excellent communication skills.
• Work independently and proactively.
• Good ISO/GCLP, CAP, POCT, Blood Bank and JCIA quality system knowledge.
• Process Management: Experience in basic process management tools and techniques required.

SKILLS AND COMPETENCIES

• Computer literacy.
• Must maintain confidentiality.
• Have good customer care skill/ experience.
• A good team player.
• Integrity, truthfulness, and capability of using both hands.
• Willingness to train and impart knowledge to staff.
• Willingness to learn and develop in the career path.

Application Deadline: 20 March 2025.