Quality Analyst – Sterilization Technologies

About the role

The Quality Analyst supports the Applied Sterilization Technologies (AST) site in Costa Rica by managing the Quality Management System (QMS) and ensuring compliance with multiple international standards. Working onsite, the analyst leads investigations, drives continuous improvement, and collaborates across functions to maintain product quality and regulatory adherence.

Key responsibilities

• Coordinate daily activities and mentor Quality Technicians and Senior Quality Technicians.
• Oversee and execute product and report pre‑reviews, releases, and non‑conformance investigations.
• Lead corrective actions, CAPA, and continuous improvement initiatives using statistical methods.
• Perform internal audits at AST facilities, generate audit reports, and manage remediation.
• Develop, update, and maintain Quality System policies, procedures, and documentation.
• Analyze data, conduct statistical analyses, and recommend process enhancements.
• Monitor and report quality performance metrics.
• Train employees on quality principles, corrective actions, and statistical techniques.
• Lead Quality System programs such as Calibration, Maintenance, Training, CAPA, Complaints, Supplier Quality Management, Document Control, Change Control, and Risk Management.

Required profile

• Experience with QMS implementation and compliance (ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMP, ISO 17025, ISO 11137, ISO 11135).
• Proven ability to lead complaint and CAPA investigations and supplier quality improvement projects.
• Strong statistical analysis and problem‑solving skills.
• Ability to conduct internal audits and manage corrective actions.
• Effective communication with customers and cross‑functional teams.
• On‑site availability Monday‑Friday, 8 am‑5 pm.

Required skills

• ISO 9001, ISO 13485, FDA 21 CFR Part 820, EU GMP, ISO 17025, ISO 11137, ISO 11135 knowledge
• Statistical analysis (e.g., Minitab, Excel)
• CAPA management
• Internal auditing
• Document control and change control
• Calibration and maintenance procedures
• Risk management
• Supplier quality management