The Production Officer – Medical Diagnostic Devices is responsible for the planning, supervision, and execution of manufacturing operations for in vitro diagnostic (IVD) kits, lateral flow devices, and other medical diagnostics. The role entails oversight of formulation, reagent dispensing, membrane coating, assembly, labeling and packaging processes in compliance with ISO 13485, current Good Manufacturing Practices (cGMP) and local regulatory requirements. The officer will manage production personnel, ensure batch traceability and collaborate with quality assurance, R&D and maintenance teams to deliver high-quality, regulatory-compliant diagnostic products. The ideal candidate must demonstrate technical expertise in diagnostics manufacturing and a strong understanding of cleanroom and sterility requirements for medical device production.

Key Duties and Responsibilities:

1. Plan, organize and supervise day-to-day production activities of diagnostic devices in accordance with batch production records and SOPs.
2. Oversee raw material preparation, reagent formulation and semi-automated/automated production processes such as dispensing, laminating, die-cutting, and assembly.
3. Monitor critical process parameters and environmental conditions in cleanroom and controlled zones.
4. Ensure adherence to ISO 13485, GMP and internal quality management system (QMS) during all manufacturing activities.
5. Maintain accurate production documentation, equipment logs, and material traceability records.
6. Train and manage production staff to uphold compliance, productivity and safety standards.
7. Participate in validation, scale-up and troubleshooting of production processes and new device formats.
8. Support internal and external audits by ensuring documentation and operational readiness.
9. Coordinate preventive maintenance and calibration of equipment with engineering and QA teams.
10. Drive continuous improvement initiatives to enhance efficiency, reduce waste and improve quality.

Academic Qualifications:
Bachelor’s degree in Biomedical Engineering, Industrial Chemistry, Biotechnology, Medical Laboratory Sciences or a related field. Certification or training in ISO 13485 and GMP is an added advantage.

Experience and Competencies:

1. Minimum of 3–5 years’ experience in medical diagnostics or medical device manufacturing.
2. Hands-on experience in the production of lateral flow devices, ELISA kits, or other IVD technologies.
3. Sound knowledge of cleanroom operations, device assembly workflows, and aseptic handling.
4. Familiarity with ISO 13485:2016, cGMP, and QMS documentation requirements.
5. Demonstrated ability to supervise production teams and work in a regulated manufacturing environment.
6. Strong problem-solving, documentation, and cross-functional coordination skills.