Quality Systems Lead: Compliance & Process Excellence

BD; El Paso (TX); On-site; USD 120,000 - 150,000; Full time

Job summary

Becton Dickinson in El Paso, TX, is seeking a senior Quality Systems professional to lead assigned QA processes and guide QA personnel. The role focuses on CAPA, audits, regulatory compliance, and process optimization, with operations anchored in a regulated healthcare environment.

The candidate should have a strong background in QMS, CAPA, Change Control, and regulatory affairs, and be capable of driving improvements across the Quality footprint while collaborating across functions.

Qualifications

• Bachelor's Degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, Business Administration, or related discipline.
• Minimum 5-8 years of experience in Quality Systems, Quality Assurance, Quality Compliance, or regulated industry environments (preferred).
• Experience in multiple Quality System processes preferred.
• Experience supporting regulatory inspections and audits.

Responsibilities

• Serve as the technical lead for assigned Quality System processes.
• Provide day-to-day guidance to Quality Systems personnel.
• Support workload planning, prioritization, and resource coordination.
• Act as the escalation point for complex quality and compliance issues.
• Drive consistent application and interpretation of quality procedures and regulatory requirements.
• Support Quality Management System initiatives and KPAs.
• Lead projects focused on compliance improvements and process optimization.
• Provide oversight for one or more Quality System processes as needed.
• Facilitate escalation of systemic product or process issues affecting the Quality System.
• Support CAPA activities including initiation, investigation, root cause analysis, action development, implementation, and effectiveness verification.
• Support audit planning, execution, reporting, and follow-up activities.
• Facilitate corrective actions resulting from audits and inspections.
• Support management review activities and quality governance forums.
• Prepare quality system metrics, dashboards, and performance reports.
• Ensure compliance with applicable regulations, standards, and procedures.
• Participate in regulatory inspections and customer audits.
• Support responses to audit observations and commitments.
• Support development and analysis of Quality System performance metrics.
• Monitor process effectiveness and identify opportunities for improvement.
• Conduct trend analysis to identify emerging compliance risks.
• Use data to drive risk-based decision-making and continuous improvement.

Skills

QMS knowledge

CAPA

Change Control

Audit & inspections

Root cause analysis

Communication

Project management

Bilingual English/Spanish

Education

Bachelor's Degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, Business Administration

Job description

Becton Dickinson in El Paso, TX, is seeking a senior Quality Systems professional to lead assigned QA processes and guide QA personnel. The role focuses on CAPA, audits, regulatory compliance, and process optimization, with operations anchored in a regulated healthcare environment.

The candidate should have a strong background in QMS, CAPA, Change Control, and regulatory affairs, and be capable of driving improvements across the Quality footprint while collaborating across functions.