Overview

Reporting to the Manager, Laboratory Quality, the Analyst, Laboratory Quality is responsible for the daily operations of laboratory quality, ensuring compliance with accreditation and regularly standards, performing internal audits, maintaining the document management system by updating policies and procedures and guiding quality control practices within the laboratory. The Analyst, Laboratory Quality maintains standard performance of laboratory staff and works closely with technical and non-technical operations. The Analyst, Laboratory Quality trains, mentors, and evaluates laboratory staff to ensure quality control, safety, and record maintenance, in coordination with Quality and Safety Leadership.

Responsibilities

Annual Key Performance Indicators

• Regulatory audit performance with scores no less than 95% compliance.
• Regulatory audit non-conformities to be closed within six weeks of audit report.

• Internal audits:

o Conduct a minimum of 90% of assigned audits each month as per the QA Verification Schedule and submit the finding summary report within one week of audit completion.
o Follow up of internal audit findings to be completed/closed out from the system within 60 days of the raised date * Annual Quality Management System (QMS) Meeting to be conducted within the first quarter (Q1) for each site within the organization\xe2\x80\x99s network and quarterly follow ups of the approved action plan to be followed up and documented on the QMS tracker

• Monthly reports/presentation slides to be submitted to Line Manager no later than 2 working days before the designated/assigned meeting date
• Present a minimum of 2 quality related training/CME session for the organization\xe2\x80\x99s caregivers on an annual basis.
• Ensure

72 hour initial investigation of assigned non-conformities (i.e. CAPAs) are adhered to and provide justification for any outliers Follow up with assigned CAPAs/OVRs for effective and appropriate corrective action with uploaded evidence of compliance (where applicable) for closure within 30-60 days of the raised date. * Lead at least 1 continuous improvement (CI) project using the FOCUS-PDCA and/or RCA templates on an annual basis

Accreditation

• Perform internal audits and prepare audit reports as per QA verification schedule
• Oversee accreditation application, follow up with changes to scope and monitor activities including self-inspection and ongoing competency of caregivers.
• Assist with responses to regulatory complaints and inspection
• Follow up with monthly proficiency testing (PT/EQA) evaluation reports to ensure timely review, necessary documentation of investigation reports and signatures are completed within 30 days of receipt.
• Remain current on and serve as an expert in regulatory and

accreditation requirements (i.e. DOH, DHA, JCI, CAP, AABB, ISO, etc.). * Manage the document management system (i.e. updating SOPs, monitoring of draft approval rate to ensure target is met, obsoleting outdated documents, appropriate distribution of active documents and ensuring timely acknowledgement of SOPs)

• Be familiar with the organization\xe2\x80\x99s Standard Operating Procedures (SOPs) for current and new testing
• In collaboration with NRL Scientific team, plan the validation process for new test procedures and ensure they conform to standard requirements specified by local and international accreditation agencies and review documentation for acceptability as per standards of practice.
• Oversee and ensure compliance with the overall safety and risk assessment processes as outlined in the annual quality/safety plan.

Data Analysis / Process Improvement

• Use data to identify systems-based improvement opportunities.
• Continuously monitor and evaluate quality outcomes across NRL labs, noting trends, and identifying and prioritizing opportunities to improve.
• Facilitate process improvement activities as needed to achieve quality improvement goals.
• Develop corrective action plans to address any non-conformance issues identified through audits, customer complaint investigations or accident investigations.
• Provide training and guidance for corrective actions and ensure plans are implemented, followed and effective.

Engaging with Stakeholders

• Participate in the development and implement communication plans. Foster open communication by offering, encouraging, and accepting suggestions from caregivers regarding department operations.
• Train, mentor and evaluate caregivers to ensure quality control, safety and record maintenance in coordination with technical/scientific Leadership.
• Participate in the development of and provide training of the organization\xe2\x80\x99s Quality Management System activities to include Environmental Health and Safety (EHS) plans, risk management, and ethics and compliance

Quality Meeting

• Actively attend and participate in monthly, regularly scheduled meetings and provide updates to management as delegated
• Provide monthly/quarterly quality metric reports and/or presentations to management as delegated/assigned

Continuous Medical Education

• Required to keep up-to-date with developments in the field, with a minimum of 20 CME credits over a period of two years to renew professional license (as applicable)

Qualifications

UAE National only.

• BSc in Medical Technology with appropriate clinical internship in Laboratory Technology or Biomedical Science
• Minimum of three (3) years as Medical Technologist; two years of which must have been working in a facility with Quality Management System or accreditation award
• Minimum of two (2) years\xe2\x80\x99 experience in laboratory quality management system department.

Mubadala Health