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Quality Control Manager – IVD & Medical Devices

Microhaem Scientifics

Senior 🇬🇧 English
ISO 13485 ISO 17025 CAPA statistical process control analytical method validation equipment qualification calibration regulatory submissions audit readiness

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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Microhaem Scientifics