Quality Analyst (Sunday to Thursday)

About the role

The Quality Analyst supports the Applied Sterilization Technologies (AST) site in Costa Rica by administering the Quality Management System, ensuring compliance with ISO, FDA, EU GMP and other regulatory standards, and driving continuous improvement.

Key responsibilities

• Coordinate day‑to‑day activities and provide technical guidance to Quality Technicians and Senior Quality Technicians.
• Oversee product and report pre‑reviews and releases, including handling non‑conformances and customer communication.
• Lead complaint and CAPA investigations, supplier quality initiatives, and continuous‑improvement projects using statistical techniques.
• Perform internal audits at other AST facilities, generate audit reports and manage remediation actions.
• Develop, update and maintain Quality System policies, procedures and related documentation.

Required profile

• Bachelor’s degree in a scientific or related technical field.
• Minimum 1 year experience in manufacturing/quality engineering or quality systems within an ISO‑certified environment.
• Proficiency in English (spoken, reading and writing).
• Experience in medical‑device or other regulated industries preferred.

Required skills

• Statistical analysis and data‑driven process improvement.
• Proficiency with Microsoft Excel, Word and PowerPoint.
• Familiarity with QMS software and regulatory standards (ISO, FDA, EU GMP).