Microbiologist / Quality Assurance Executive

Role & responsibilities

1. Microbiological Testing: Design, develop, and execute microbiological testing protocols to evaluate the safety and efficacy of medical devices.

2. Sterilization Validation: Plan, execute, and document sterilization validation protocols to ensure compliance with regulatory requirements.

3. Microbiological Risk Assessment: Conduct microbiological risk assessments to identify potential hazards associated with medical devices.

4. Quality System Management: Participate in the development, implementation, and maintenance of the quality system, including standard operating procedures (SOPs) and quality policies.

5. Regulatory Compliance: Ensure compliance with relevant regulatory requirements, including FDA, ISO, and EU directives.

6. Collaboration: Work closely with cross-functional teams, including Research and Development, Manufacturing, and Quality Assurance.

7. Documentation: Maintain accurate and detailed records of testing, validation, and compliance activities.

8. Continuous Improvement: Identify areas for process improvement and implement changes to optimize microbiological testing and validation protocols.

Preferred candidate profile

Knowledge: Strong understanding of microbiological principles, including sterilization, disinfection, and contamination control.

Regulatory Knowledge: Familiarity with regulatory requirements, including FDA, ISO, and EU - MDR directives.