Quality Analyst – Applied Sterilization Technologies

About the role

The Quality Analyst supports the Applied Sterilization Technologies (AST) site in Costa Rica by administering the Quality Management System and ensuring compliance with multiple international standards. The role involves leading investigations, driving continuous improvement, and coordinating product releases that contain non‑conformances.

Key responsibilities

• Coordinate daily activities and provide technical guidance to Quality Technicians.
• Oversee and execute product/report pre‑reviews and releases, including customer communication.
• Lead corrective actions, CAPA investigations, and continuous improvement initiatives.
• Perform internal audits at other AST facilities, generate audit reports and manage remediation.
• Develop and maintain Quality System policies, procedures and documentation revisions.
• Analyze collected data, perform statistical analyses and recommend process improvements.
• Monitor, analyze and report quality performance metrics.
• Train and coach employees on quality principles and statistical methodologies.
• Collaborate with cross‑functional teams and other STERIS facilities on quality‑related projects.

Required profile

• Bachelor’s degree in a scientific or technical field.
• Minimum 1 year of experience in manufacturing/quality engineering or quality systems, preferably in a regulated environment.
• Proficiency in English (spoken, written, read).
• Experience working with ISO‑certified quality management systems.

Required skills

• Statistical analysis techniques.
• Microsoft Excel, Word and PowerPoint.
• QMS software systems.
• Knowledge of ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMP, ISO 17025, ISO 11137, ISO 11135.
• Laboratory testing (microbiological/chemical) and calibration procedures.