- Perform microbiological testing of raw materials, in-process samples, and finished products (bandages, surgical dressings, and related medical devices).
- Conduct sterility, endotoxin, bioburden, and environmental monitoring tests in compliance with pharmacopeia and regulatory standards.
- Ensure routine monitoring of cleanroom and controlled environments.
- Support validation and calibration of microbiology laboratory equipment (autoclaves, incubators, particle counters, etc.).
- Maintain accurate test records, logbooks, and documentation in accordance with GMP/GLP guidelines.
- Ensure strict compliance with ISO 13485, GMP, and regulatory standards applicable to medical devices.
- Assist in root cause analysis and corrective & preventive actions (CAPA) for microbiological deviations.
- Coordinate with Production and QA teams to support continuous product quality improvements.
- Participate in audits (internal, external, and regulatory) and ensure lab readiness.
Skills: medical devices,deviations,calibration,microbiology,compliance
