Quality Analyst

About the role

The Quality Analyst in the Applied Sterilization Technologies (AST) Costa Rica location assists in administering the Quality Management System (QMS) to ensure compliance with ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137, ISO 11135 and other regulatory standards. The role also leads complaint and CAPA investigations, supplier quality improvement initiatives, continuous‑improvement activities and corrective actions using statistical techniques.

Key responsibilities

• Coordinate day‑to‑day activities and provide technical guidance to Quality Technicians and Senior Quality Technicians.
• Oversee and execute product and report pre‑reviews and releases, including handling non‑conformances and customer communication.
• Initiate and participate in corrective actions, problem‑solving activities and continuous‑improvement projects.
• Perform internal audits at other AST facilities, generate audit reports and manage remediation.
• Develop and maintain Quality System policies, procedures and documentation revisions.
• Review data, conduct statistical analyses and recommend process improvements.
• Monitor, analyze and report quality performance metrics.
• Train and coach employees on quality principles, corrective actions and statistical methods.

Required profile

• Bachelor’s degree in a scientific or related technical field.
• Minimum of 1 year of combined manufacturing/quality engineering or quality systems experience in an ISO‑certified environment.
• Proficiency in English (spoken, reading, writing).
• Experience in a regulated industry (medical devices preferred) and familiarity with FDA QSR/EU GMP regulations.

Required skills

• Statistical analysis techniques.
• Quality Management System (QMS) software.
• Microsoft Excel, Word and PowerPoint.
• Laboratory testing (microbiological and chemical).
• Knowledge of ISO 9001, ISO 13485, ISO 17025, ISO 11137, ISO 11135 standards.
• Regulatory compliance (FDA 21 CFR Part 820, EU GMP).