Quality Assurance Associate - Process Improvement & CAPA

ELITechGroup Inc.; Logan (UT); On-site; USD 65,000 - 85,000; Full time

Job summary

ELITechGroup Inc. is seeking a Quality Assurance professional to support the Quality Management System and related processes across manufacturing and QC operations.

You will write and execute quality plans, establish control points, and lead CAPA investigations to drive continuous improvement while ensuring compliance with ISO 13485 and FDA quality requirements. The role includes audits, training, and documentation control.

Qualifications

• Bachelor's degree in Life Science or Engineering plus one year quality related experience or three years direct Quality/Regulatory experience.
• Knowledge of quality planning, CAPA systems, auditing, root cause analysis, and problem solving.
• Working knowledge of ISO 13485 and/or FDA 21 CFR 820 quality relations.

Responsibilities

• Support Quality Management System processes, procedures, and records.
• Write and execute quality plans and monitor progress against quality plans.
• Establish quality control points to monitor progress and quality.
• Perform CAPA investigations and implement corrective/preventive actions.
• Conduct internal audits and participate in external audits as assigned.
• Provide quality training and promote adherence to processes and procedures.
• Identify opportunities for process improvement and implement changes to reduce variation.

Skills

Quality planning

CAPA

Auditing

Root cause analysis

Problem solving

Education

Bachelor's degree in Life Science or Engineering

Job description

ELITechGroup Inc. is seeking a Quality Assurance professional to support the Quality Management System and related processes across manufacturing and QC operations.

You will write and execute quality plans, establish control points, and lead CAPA investigations to drive continuous improvement while ensuring compliance with ISO 13485 and FDA quality requirements. The role includes audits, training, and documentation control.