Senior Quality Engineer: Process Excellence & CAPA

Becton Dickinson; Sumter (SC); On-site; USD 70,000 - 90,000; Full time

Job summary

BD Sumter seeks a Quality Engineer to perform statistical analysis of processes, identify root causes of defects, and lead CAPA investigations. You will coordinate quality programs, collect data for trend analysis, and support regulatory compliance in a manufacturing environment.

Required BA/BS in engineering/science/math with 3 years QA/manufacturing experience (or MSc with 2 years). Strong communication and knowledge of IQ/OQ/PQ validations are essential. Sumter, SC location.

Qualifications

• BA/BS in Engineering, Sciences or Mathematics required.
• 3 years QA/manufacturing experience or MSc with 2 years.
• Understanding of statistical tools: control limits, SPC, 8D, 5-Why.
• Excellent written and verbal communication skills.
• Knowledge of Validations (IQ/OQ/PQ) and DOEs; ISO13485 preferred.
• Six Sigma training preferred.

Responsibilities

• Perform statistical analysis of processes and designs.
• Identify root causes of defects and waste; recommend actions.
• Coordinate Quality Awareness Program within the plant.
• Lead CAPA investigations and action plans.
• Collect data for trend analysis and SPC monitoring.
• Support regulatory compliance (QSR, FDA) and vendor audits.

Skills

Statistical analysis

Root cause analysis

CAPA investigations

Data trend analysis

Problem solving

Education

BA/BS in Engineering/Sciences/Mathematics

MSc degree (optional)

Tools

Validation protocols (IQ/OQ/PQ)

Job description

BD Sumter seeks a Quality Engineer to perform statistical analysis of processes, identify root causes of defects, and lead CAPA investigations. You will coordinate quality programs, collect data for trend analysis, and support regulatory compliance in a manufacturing environment.

Required BA/BS in engineering/science/math with 3 years QA/manufacturing experience (or MSc with 2 years). Strong communication and knowledge of IQ/OQ/PQ validations are essential. Sumter, SC location.