Senior Quality Engineer: Data-Driven Process Excellence

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

Job summary

Becton, Dickinson and Company (BD) is seeking a Quality Assurance professional at its Sumter, SC facility. The role focuses on statistical analysis of processes, defect reduction, and guiding CAPA actions to improve product quality and costs.

The position requires a BA/BS in engineering/sciences or math, with 3 years of QA/manufacturing experience (or MSc with 2 years). Knowledge of validation protocols IQ/OQ/PQ and DOEs is essential, with ISO13485:2016 and Six Sigma being a plus.

Qualifications

• BA/BS Degree (Engineering, Sciences, Mathematics) required.
• 3 years work experience in Quality Assurance/Manufacturing OR MSc Degree with 2 years experience.
• Proven understanding of statistical/investigative tools: control limits, SPC, 8D, 5-Why, P charts, probability studies.
• Effective written and verbal skills with ability to take responsibility with minimal direction.
• Working knowledge of Validations (IQ, OQ, PQ) and DOEs.
• ISO13485:2016 knowledge preferred; Six Sigma training preferred.

Responsibilities

• Use statistical engineering to initiate capability studies and reduce defects and cost of quality.
• Support Plant Validation Program with data gathering, analysis, and validation efforts.
• Lead root-cause investigations and advise corrective actions and CAPA plans.
• Collect data from critical processes for trend analysis and maintain statistical process control.
• Coordinate quality activities across the plant and ensure regulatory and contractual compliance.
• Provide test and statistical support for customer complaint issues and vendor quality evaluations.

Skills

Statistical analysis

SPC

CAPA investigations

Root cause analysis

Validation IQ/OQ/PQ

QA in manufacturing

Documentation skills

Education

BA/BS Degree (Engineering, Sciences, Mathematics)

MSc Degree in a relevant field

Job description

Becton, Dickinson and Company (BD) is seeking a Quality Assurance professional at its Sumter, SC facility. The role focuses on statistical analysis of processes, defect reduction, and guiding CAPA actions to improve product quality and costs.

The position requires a BA/BS in engineering/sciences or math, with 3 years of QA/manufacturing experience (or MSc with 2 years). Knowledge of validation protocols IQ/OQ/PQ and DOEs is essential, with ISO13485:2016 and Six Sigma being a plus.