Senior Quality Leader – NCI, CAPA & Change Control

Becton Dickinson; El Paso (TX); On-site; USD 110,000 - 170,000; Full time

Job summary

BD is seeking a Quality Governance Leader to own the NCI, CAPA, and Change Control programs at the El Paso site. You will drive data-driven improvements ensuring regulatory compliance and robust quality-system performance across products.

You will lead cross-functional teams, set accountability, and partner with QA, Regulatory, and operations to close gaps and accelerate effective corrective actions. A strong background in FDA guidelines and 21 CFR is expected.

Qualifications

• Experience leading quality governance programs and ensuring regulatory compliance.
• Strong ability to drive investigations, data-driven decision making, and risk assessment.

Responsibilities

• Own and continuously improve the site NCI process, including intake, classification, containment, investigation, root cause determination, product-impact assessment, approval, and closure.
• Lead CAPA initiation, risk-based prioritization, action planning, implementation, verification of effectiveness, and closure.
• Own the Change Control governance from proposal to closure with cross-functional collaboration.
• Define, monitor, and report leading and lagging quality metrics for NCI, CAPA, and Change Control.
• Lead and coach QA personnel responsible for investigations, CAPA, and Change Control.

Skills

Quality governance

Investigations leadership

CAPA management

Change control

Education

Bachelor's degree

Job description

BD is seeking a Quality Governance Leader to own the NCI, CAPA, and Change Control programs at the El Paso site. You will drive data-driven improvements ensuring regulatory compliance and robust quality-system performance across products.

You will lead cross-functional teams, set accountability, and partner with QA, Regulatory, and operations to close gaps and accelerate effective corrective actions. A strong background in FDA guidelines and 21 CFR is expected.