The Quality Control Officer Medical Diagnostic Devices is responsible for performing, reviewing and overseeing quality control testing and inspection activities related to raw materials, components, intermediates and finished in vitro diagnostic (IVD) products. The role ensures compliance with ISO 13485, cGMP, internal specifications and applicable regulatory standards. The QC Officer will handle analytical testing, documentation, environmental monitoring, and contribute to the validation of testing methods. This position plays a key role in ensuring the performance, accuracy and safety of medical diagnostic devices prior to release to market. The ideal candidate should have hands-on experience with diagnostic product testing, good laboratory practices and a sound understanding of regulatory compliance for IVDs.

Key Duties and Responsibilities:

1. Perform physical, chemical, and functional testing of raw materials, components and finished diagnostic devices.
2. Conduct performance verification for lateral flow tests, reagents, and diagnostic kits in accordance with product specifications.
3. Review and approve QC documentation including Certificates of Analysis (CoAs), test reports and inspection checklists.
4. Carry out sampling and environmental monitoring of cleanrooms and production areas per quality plan.
5. Monitor calibration status and proper functioning of analytical equipment and reference standards.
6. Document all test results accurately in laboratory notebooks, logbooks, or LIMS as per ALCOA+ data integrity standards.
7. Investigate out-of-specification (OOS) or non-conforming results and support root cause analysis and CAPA processes.
8. Participate in the qualification/validation of test methods and analytical instruments.
9. Collaborate with QA, production, and regulatory affairs teams during audits and inspection readiness activities.
10. Adhere to Good Laboratory Practices (GLP), safety protocols, and cleanroom gowning procedures.

Academic Qualifications:
Bachelor’s degree in Biomedical Sciences, Industrial Chemistry, Medical Laboratory Technology, Biochemistry, or a related scientific discipline.

Experience and Competencies:

1. Minimum of 3–5 years of experience in quality control for medical diagnostics, IVDs, or regulated laboratory environments.
2. Sound understanding of ISO 13485, cGMP and testing requirements for diagnostic devices.
3. Experience in testing lateral flow assays, reagents or ELISA-based devices is an advantage.
4. Strong documentation and data integrity skills; familiarity with LIMS or equivalent systems.
5. Knowledge of cleanroom practices and environmental monitoring techniques.

Ability to work independently, manage multiple tasks and collaborate across departments.