QA Specialist: Audits, CAPA & Process Improvement

OnTrac; Commerce (CA); Hybrid; USD 105,000 - 157,000; Full time

Job summary

OnTrac is seeking a Quality Assurance Consultant to support the organization’s quality management initiatives, audits, and CAPA programs. You will work across operations, engineering, and compliance to ensure processes meet established quality standards and regulatory requirements.

The role emphasizes data analysis, corrective action management, and continuous improvement to enhance operational performance, customer satisfaction, and compliance.

Qualifications

• Knowledge of QA methodologies, auditing practices, and CAPA processes.
• Strong root cause analysis and problem-solving skills.
• Experience with continuous improvement and quality systems.

Responsibilities

• Conduct quality reviews, inspections, and audits to verify compliance with standards.
• Analyze defects, complaints, and deviations to identify root causes and implement CAPA.
• Develop, update, and manage quality records, procedures, and reports for compliance.
• Collaborate with cross-functional teams to drive process improvements and reduce defects.
• Monitor regulatory requirements and support internal/external audits.

Skills

QA methodologies

Auditing practices

Root cause analysis

CAPA

Continuous improvement

Education

Bachelor's degree or equivalent

Tools

Office software

QA tools

Job description

OnTrac is seeking a Quality Assurance Consultant to support the organization’s quality management initiatives, audits, and CAPA programs. You will work across operations, engineering, and compliance to ensure processes meet established quality standards and regulatory requirements.

The role emphasizes data analysis, corrective action management, and continuous improvement to enhance operational performance, customer satisfaction, and compliance.