Quality Analyst

Position Summary

The Quality Analyst in the Applied Sterilization Technologies (AST) Costa Rica location is responsible for assisting in the administration of the Quality Management System (QMS) at the site to ensure compliance with ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMPs, ISO 17025, ISO 11137, ISO 11135, and other applicable regulatory standards.

This role leads complaint and CAPA investigations, supplier quality improvement initiatives, continuous improvement activities, and corrective actions through the application of statistical techniques and established quality principles.

The Quality Analyst executes activities related to the development, implementation, maintenance, and continuous improvement of STERIS Quality Systems. The role also supports production and quality operations by coordinating and performing problem-solving investigations, conducting pre-reviews, and approving the final acceptance/release of processing runs containing non-conformances.
Additionally, the position is responsible for activities related to quality and regulatory compliance to ensure all product processing requirements are met according to customer specifications, including calibrations, dosimetry results, test method generation, audits, scheduling, validations, recordkeeping, and reporting.

This position requires working onsite in our Costa Rica campus 8am to 5pm Monday - Friday.

What you will do as a Quality Analyst

• Coordinate day-to-day activities and provide technical guidance, mentoring, and oversight to Quality Technicians and Senior Quality Technicians.
• Oversee all product and/or report pre-reviews and releases performed by Quality Technicians and Senior Quality Technicians.
• Execute product and/or report releases for processing runs or laboratory samples containing non-conformances, including customer communication and leading associated investigations.
• Initiate and participate in corrective actions, problem-solving activities, and continuous improvement initiatives.
• Perform internal audits at other AST facilities, identify non-compliances, generate audit reports, and manage remediation activities assigned by the Site Quality Manager.
• Develop new Quality System policies and procedures and maintain revisions to existing documentation.
• Review collected data, perform statistical analyses, and recommend process improvements to enhance quality.
• Monitor, analyze, and report quality performance metrics.
• Train and coach STERIS employees on quality principles, effective corrective actions, and appropriate statistical methodologies.
• Collaborate with cross-functional departments and other STERIS facilities on quality-related initiatives.
• Lead Quality System programs, including:
  • • Calibration
    • Maintenance
    • Training
    • CAPA
    • Complaints
    • Non-conformances
    • Supplier Quality
    • Management Review
    • Operational Qualifications
    • Document Control
    • Change Control
    • Risk Management

   

• Ensure compliance with all documented internal policies, procedures, standards, customer requirements, and applicable regulatory requirements.
• Perform other duties as assigned.

The Experience, Skills and Abilities Needed

Required: 

• Bachelor’s degree (Scientific or related technical field)
• Minimum of 1 year of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• Minimum of 1 year of experience working in an ISO certified environment required.
• Must be proficient in English (speak, read, write).

Preferred: 

• Minimum of 1 year experience with medical device or other regulated industries, preferred.
• Working knowledge of FDA QSR/ EUGMP regulations strongly preferred.
• Experience working in a laboratory or in laboratory environments involving microbiological/chemical testing and analysis.
• Knowledge of Quality Systems and QMS  software systems

Other:

• Excellent problem-solving skills
• Focus on identification of potential issues and continuous improvement.
• Experience working on cross-functional teams and on own initiative.
• Demonstrated excellent organizational, oral and written communications skills.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
• Ability to work in a fast-paced, regulated environment with strict deadlines.
• Mathematical skills including practical application of fractions, percentages, ratios, proportions and algebra.

Working Conditions

• Work is performed in a manufacturing/operations environment.