Quality Analyst (Tuesday to Saturday)

About the role

The Quality Analyst at STERIS's Applied Sterilization Technologies (AST) Costa Rica site supports the administration of the Quality Management System (QMS) so that the site complies with ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137, ISO 11135 and other applicable standards. The role leads complaint and CAPA investigations, supplier quality improvement, continuous improvement and corrective actions using statistical techniques, and works onsite Tuesday to Saturday, 6:00 a.m. to 3:00 p.m.

Key responsibilities

• Mentor, guide and oversee Quality Technicians and Senior Quality Technicians, and approve their pre-reviews and releases, including those of non-conforming runs.
• Lead corrective actions, problem-solving and continuous improvement, and run internal audits at other AST facilities.
• Develop and maintain Quality System policies, procedures and documentation.
• Analyze data statistically, report quality metrics and recommend process improvements.
• Train staff on quality principles, corrective actions and statistical methods.
• Lead Quality System programs: calibration, maintenance training, CAPA, complaints, non-conformances, supplier quality, management review and operational control.
• Ensure compliance with internal policies, customer requirements and regulatory standards, and handle calibrations, dosimetry, validations, audits, recordkeeping and reporting.

Required profile

• Bachelor's degree in a scientific or related technical field.
• At least 1 year of combined manufacturing/quality engineering and/or quality systems experience.
• At least 1 year of experience in an ISO-certified environment; medical device or regulated industry experience preferred.
• Proficiency in English (speak, read, write).
• PC experience and familiarity with Excel, Word and PowerPoint.

Required skills

• Working knowledge of FDA QSR/EU GMP strongly preferred.
• Knowledge of Quality Systems and QMS software.
• Mathematical skills: fractions, percentages, ratios, proportions and algebra.
• Problem-solving, cross-functional teamwork and strong written and oral communication.