Quality Assurance Officer

Job title : Quality Assurance Officer

Job Purpose

• The Laboratory Quality Assurance Officer will ensure the highest standards of quality, accuracy, and compliance across all diagnostics operations.
• This role involves implementing and monitoring quality management systems, conducting audits, managing documentation, and ensuring adherence to regulatory requirements.

Job Responsibilities

• Develop, implement, and maintain the quality management system in line with applicable regulatory standards.
• Oversee documentation control, including SOPs, policies, and quality records.
• Coordinate internal audits and manage corrective and preventive action processes.
• Ensure compliance with local regulations (HEFAMAA, MLSCN, and NNRA) and ISO 15189:2022 requirements.
• Prepare for and support external audits and inspections.
• Monitor changes in regulatory requirements and implement updates.
• Identify opportunities for process improvement and risk reduction.
• Support in updating staff on quality procedures, documentation, and compliance.
• Participate in quality meetings and report on key performance indicators.
• Investigate incidents, deviations, and non-conformances.
• Ensure timely reporting and resolution of quality issues.
• Maintain records of incidents and corrective actions.
• Manage quality-related data, including proficiency testing results, equipment calibration, and validation records.
• Ensure confidentiality, integrity, and accessibility of quality documentation.

Requirements

• Bachelor’s Degree in medical laboratory science or biological sciences.
• Certification in Quality Management will be an added advantage
• Minimum of 2 years’ experience in a laboratory quality assurance role within a healthcare or diagnostic setting.
• Experience with laboratory accreditation processes is essential.

Experience:

• Strong knowledge of quality standards (ISO 15189, ISO 9001).
• Experience conducting internal audits and managing CAPA.
• Excellent attention to detail and organizational skills.
• Proficient in data analysis and report writing.
• Strong communication and training skills.
• Ability to work collaboratively in a multidisciplinary environment.