Senior Quality Leader - NCI, CAPA & Change Control

Hardware FYI; El Paso (TX); On-site; USD 120,000 - 160,000; Full time

Job summary

Becton, Dickinson, and Company (BD) seeks a senior Quality leader to govern NCI, CAPA and Change Control at the El Paso site. You will build and drive robust quality-system processes to ensure product quality and patient safety across manufacturing and audits.

Lead cross-functional teams, mentor quality professionals, and partner with Regulatory Affairs to sustain compliance and improvements through data-driven metrics and risk management.

Qualifications

• Bachelor’s degree in Engineering, Science, or Pharmacy required.
• Master’s degree preferred for advanced governance roles.

Responsibilities

• Own and improve site NCI process from intake to closure.
• Ensure investigations are scientifically sound and timely.
• Provide QA oversight for corrections, containment, risk assessments.
• Ensure OOS/OOT investigations align with FDA guidance and reporting.
• Establish standards for tools, analysis, and recurrence prevention.
• Trend NCI data to identify repeat events and preventive actions.
• Lead CAPA initiation, risk prioritization, action planning, and closure.
• Ensure CAPAs address root causes with measurable deliverables.
• Chair CAPA Review Board and drive timely issue removal.
• Assess effectiveness checks with objective evidence.
• Lead Change Control governance from proposal to closure.
• Ensure changes impact product quality and regulatory filings.
• Collaborate with Regulatory Affairs on reportability of changes.
• Define prereqs, testing, validation, and post-implementation monitoring.
• Lead cross-functional change review forums for proper approvals.
• Define metrics for NCI, CAPA, and Change Control performance.
• Present quality-system health to leadership and management reviews.
• Serve as SME for NCI, CAPA, and Change Control during audits.

Education

Bachelor’s degree in Engineering, Science, or Pharmacy

Master’s degree preferred

Job description

Becton, Dickinson, and Company (BD) seeks a senior Quality leader to govern NCI, CAPA and Change Control at the El Paso site. You will build and drive robust quality-system processes to ensure product quality and patient safety across manufacturing and audits.

Lead cross-functional teams, mentor quality professionals, and partner with Regulatory Affairs to sustain compliance and improvements through data-driven metrics and risk management.