The Production Assistant – Medical Diagnostic Devices supports the day-to-day operations of manufacturing and assembly lines for in vitro diagnostics (IVDs), including lateral flow test strips, reagent kits, and other medical devices. The role involves assisting in material preparation, device assembly, labeling, packaging, and maintaining cleanroom standards. The position is critical in ensuring production continuity and compliance with ISO 13485, cGMP, and internal quality systems. The ideal candidate should have good manual dexterity, an understanding of cleanroom discipline, and a strong commitment to accuracy and hygiene in a highly regulated environment.

Key Duties and Responsibilities:

1. Assist in preparing materials, consumables, and reagents required for diagnostic device production.
2. Support device assembly processes including lamination, cutting, dispensing and striping under supervision.
3. Label, pouch and box test kits and components as per product specifications and work instructions.
4. Maintain proper gowning, hygiene and behavior in controlled and cleanroom areas.
5. Ensure cleanliness of workstations and assist in environmental cleaning of production zones.
6. Record batch activities, cleaning logs, and other entries in accordance with Good Documentation Practices (GDP).
7. Handle, segregate, and store raw materials, intermediates, and finished devices per SOPs.
8. Alert the supervisor of any deviations, defects, or abnormalities in production processes or equipment.
9. Support routine stock replenishment and maintain inventory of consumables used in assembly operations.
10. Participate in basic trainings related to GMP, ISO 13485, cleanroom operations, and occupational safety.

Academic Qualifications:

Minimum of Uganda Certificate of Education (UCE). A certificate in medical laboratory techniques, industrial production, or medical device assembly is an added advantage.

Experience and Competencies:

1. Minimum of 1–2 years’ experience in medical device manufacturing, diagnostics or a cleanroom production environment.
2. Understanding of basic manufacturing procedures, cleanroom behavior and hygiene standards.
3. Ability to follow written and verbal instructions with accuracy and attention to detail.
4. Physically fit and able to work in repetitive assembly tasks for extended periods.
5. Team-oriented with good discipline, integrity and communication skills.