Quality Control Manager – IVD & Medical Devices
Microhaem Scientifics
Job description
About the role
Microhaem Scientifics & Medical Supplies Limited is seeking an experienced Quality Control Manager to lead QC operations in a regulated diagnostic and medical‑device manufacturing environment in Uganda. This strategic leadership position will strengthen world‑class manufacturing and quality systems across Africa.
Key responsibilities
- Oversee QC systems for laboratory operations, analytical testing, product release and stability programmes.
- Manage method transfer, validation, verification and equipment qualification.
- Lead supplier qualification, supplier‑quality management and external laboratory coordination.
- Ensure compliance with ISO 13485, ISO 17025, WHO and other regulatory requirements.
- Drive CAPA, root‑cause analysis, non‑conformity management and continuous quality improvement.
- Prepare regulatory submissions and maintain audit readiness.
Required profile
- Master’s degree in biomedical science or related field.
- Minimum 7 years of medical‑device QC experience with hands‑on laboratory work.
- Proven experience in ISO‑aligned quality systems (ISO 13485, ISO 17025).
- Experience supporting WHO or global medical‑device regulatory submissions.
- Demonstrated leadership in building high‑performing scientific and QC teams.
Required skills
- ISO 13485 quality system implementation
- ISO 17025 laboratory accreditation
- WHO regulatory standards for IVD
- CAPA and root‑cause analysis
- Statistical process control and quality‑performance monitoring
- Analytical method validation, verification and transfer
- Laboratory equipment qualification and calibration
- Supplier quality management
- Regulatory submissions and audit readiness
What we offer
- Opportunity to apply international quality expertise in a growing African diagnostic‑manufacturing environment.
- Contribution to strengthening local scientific capability and sustainable IVD manufacturing capacity.
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Published 1 month ago
Expires 1 week from now
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