QA Engineer – Environmental Control (Level III)

About the role

The QA Engineer, Environmental Control III is responsible for developing and implementing quality plans, programs, and procedures that ensure clean‑room and microbiology environments meet company, customer and regulatory standards.

Key responsibilities

• Develop, modify and maintain quality evaluation and control plans for environmental and microbiology equipment and clean rooms.
• Analyze performance data, generate trends, report failures and create deviations related to environmental or microbiology control.
• Audit contamination control systems, ensure corrective actions meet ISO 9001/13485 standards and document compliance.
• Support internal and third‑party supplier audits, FDA quality audits and plant quality system software validation.

Required profile

• Bachelor’s degree in microbiology, biology or a related scientific field.
• 4–6 years of experience in clean‑room monitoring, environmental control or microbiology quality assurance.

Required skills

• Quality control statistics and data trending.
• Process validation and qualification.
• CAPA (Corrective and Preventive Action) management.
• Knowledge of ISO 9001 and ISO 13485 requirements.
• Contamination control procedures for clean rooms.
• Microbiology testing and analysis.