Quality Control Microbiologist

Key Responsibilities:

Conduct biosafety, sterility, and microbial limit tests on medical devices.

Perform environmental monitoring of clean rooms and production areas.

Maintain and monitor sterilization processes (e.g., autoclave, EO sterilization, etc.).

Support Quality Control (QC) and Quality Assurance (QA) activities.

Prepare and maintain testing reports, logbooks, and documentation.

Ensure compliance with ISO 13485, CE, and medical device regulatory standards.

Coordinate with production teams to identify and eliminate potential contamination risks.

Perform water testing, surface testing, and air sampling in controlled environments.

Required Skills & Qualifications

B.Sc. in Microbiology (M.Sc. preferred but not mandatory).

Knowledge of biosafety testing, sterility testing, and microbial contamination control.

Familiarity with cleanroom operations and GMP standards.

Experience with testing equipment such as incubators, autoclaves, and particle counters.

Strong understanding of medical device microbiological validation.

Good documentation and analytical skills.

Attention to detail and adherence to lab protocols.