The Quality Assurance Officer – Medical Diagnostic Devices is responsible for ensuring that all manufacturing activities, processes, and products related to in vitro diagnostic (IVD) devices comply with applicable quality standards including ISO 13485, cGMP, and national/international regulatory requirements. The officer will review batch records, monitor in-process controls, handle non-conformities, support validations and ensure documentation accuracy across production and quality systems. This role will also support internal audits, CAPA processes and regulatory inspections to ensure product safety, performance, and regulatory compliance. The ideal candidate must be experienced in quality assurance within a medical device or diagnostics environment and demonstrate a proactive approach to risk management and quality systems enforcement.

Key Duties and Responsibilities:

1. Review and approve batch records, quality control results and documentation related to medical diagnostic device production.
2. Ensure compliance with ISO 13485, cGMP, and local regulatory guidelines during manufacturing and quality control processes.
3. Perform in-process checks, environmental monitoring verification and line clearance validations in production zones.
4. Investigate and document non-conformances, deviations and product complaints; initiate and monitor CAPAs.
5. Participate in validation of new products, processes, and equipment including IQ/OQ/PQ activities.
6. Coordinate document control activities including SOPs, BMRs, logs and quality forms related to diagnostics.
7. Conduct internal audits and assist with supplier audits and regulatory inspections.
8. Support product release processes by reviewing Certificates of Analysis (CoAs), QC data and inspection reports.
9. Promote adherence to Good Documentation Practices (GDP) and data integrity (ALCOA+) principles.
10. Train production and quality staff on quality procedures, hygiene standards, and regulatory expectations.

Academic Qualifications:
Bachelor’s degree in Biomedical Engineering, Medical Laboratory Technology, Industrial Chemistry, Quality Assurance, or a related scientific field. Certification in ISO 13485 or internal auditing is an added advantage.

Experience and Competencies:

1. Minimum of 3–5 years’ experience in quality assurance for medical devices, diagnostics or pharmaceutical manufacturing.
2. Sound knowledge of ISO 13485, cGMP, GDP, and regulatory frameworks for IVDs.
3. Hands-on experience in audit preparation, CAPA management, and QA documentation control.
4. Familiarity with cleanroom classification, aseptic processing and device batch record review.
5. Strong interpersonal, organizational and analytical skills.

Ability to work collaboratively with cross-functional teams under regulatory pressure.