Quality Engineer - Drive CAPA & Process Improvement

Theoris; Warsaw (IN); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Full benefits

Job summary

Theoris is seeking a Quality Engineer to support quality systems, investigate production issues, and drive continuous improvement within a regulated manufacturing environment in Indiana.

Responsibilities include root cause analysis, CAPA support, collaboration with manufacturing and engineering to reduce defects, data trend review, and maintaining quality documentation, procedures, and work instructions while ensuring compliance with regulatory standards.

Qualifications

• Bachelor's degree in Engineering or a related technical field preferred.
• 3+ years of experience in quality engineering or manufacturing engineering.
• Experience with root cause analysis, CAPA, and continuous improvement methodologies.

Responsibilities

• Investigate quality issues and perform root cause analysis
• Support CAPA activities and implement corrective actions
• Partner with manufacturing and engineering teams to improve processes and reduce defects
• Review and analyze quality data to identify trends and improvement opportunities
• Develop and maintain quality documentation, procedures, and work instructions
• Support validation, equipment qualification, and quality improvement initiatives
• Ensure compliance with quality systems, regulatory requirements, and manufacturing standards

Skills

Root cause analysis

CAPA

Continuous improvement

Quality data analysis

Manufacturing engineering

Education

Bachelor's degree in Engineering or related technical field

Job description

Theoris is seeking a Quality Engineer to support quality systems, investigate production issues, and drive continuous improvement within a regulated manufacturing environment in Indiana.

Responsibilities include root cause analysis, CAPA support, collaboration with manufacturing and engineering to reduce defects, data trend review, and maintaining quality documentation, procedures, and work instructions while ensuring compliance with regulatory standards.