Senior Quality Engineer: Process & CAPA Leader

BD

Sumter (SC)

On-site

USD 80,000 - 110,000

Full time

7 days ago

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Job summary

BD is seeking a Quality Engineer to perform statistical analysis of processes, identify root causes of defects, and guide CAPA actions in the Sumter facility. The role requires a BA/BS (Engineering/Sciences/Math) with 3 years QA/manufacturing experience or MSc with 2 years, plus strong knowledge of statistical tools.

The ideal candidate will support validations (IQ/OQ/PQ), implement process controls, and ensure compliance with ISO13485:2016.

Qualifications

BA/BS degree in Engineering, Sciences, Mathematics or equivalent required.
Minimum of BA/BS degree and 3 years in Quality Assurance/Manufacturing or MSc and 2 years required.
Strong understanding of statistical/investigative tools (control charts, SPC, 8D, 5-Why).
Effective written and verbal skills with ability to work with minimal direction.
Knowledge of Validations (IQ/OQ/PQ) and DOEs required.

Responsibilities

Initiate capability studies to identify causes of defects and cost issues.
Guide data gathering and analysis for plant validation programs.
Lead investigations to identify root causes and implement corrective actions (CAPA).
Collect and trend data from quality KPIs and report to management.
Ensure plant-wide quality alignment and compliance with regulations.