Clinical Laboratory Quality Manager
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Industry Healthcare / Medical Founded N / A Type Private Website https://rfhhealthcare.co.ke/ Address Kangundo Road Ruai Nairobi Kenya
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Key Responsibilities:
- Develop, implement, and monitor the laboratory Quality Management System (QMS) in line with ISO 15189:2022.
- Coordinate KENAS accreditation and surveillance assessments.
- Develop and monitor the annual internal audit programme.
- Investigate and resolve nonconformities through root-cause analysis and corrective actions.
- Monitor quality indicators, laboratory performance, and improvement actions.
- Coordinate EQA/Proficiency Testing (PT) programmes.
- Maintain effective document and record control systems.
- Coordinate laboratory risk assessment and risk-management activities.
- Monitor compliance with approved SOPs, policies, and quality procedures.
- Coordinate investigation of complaints and customer feedback.
- Monitor internal quality-control performance with technical teams.
- Prepare QMS reports and present quality performance to laboratory management.
- Coordinate management review meetings and follow-up actions.
- Identify and implement opportunities for continual improvement.
- Support staff training, competency assessment, and quality awareness.
- Ensure quality records and accreditation evidence are maintained and readily available.
Qualifications & Experience:
- Bachelor's degree or higher in Medical Laboratory Sciences.
- 5-7 years' relevant clinical laboratory experience.
- Demonstrated experience in Laboratory Quality Management Systems.
- Good working knowledge of ISO 15189:2022.
- Experience in internal auditing, nonconformity management, and corrective actions.