Quality Systems Lead – Compliance & CAPA Champion

Regulatory Jobs; El Paso (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

BD is seeking a senior Quality Systems professional to lead assigned processes, guide QA teams, and drive regulatory readiness in a fast-paced medical technology environment.

The role focuses on CAPA, Change Control, training, audits, and document control, with responsibility for improving process effectiveness and complying with FDA, GMP, and ISO requirements. Strong collaboration with cross-functional teams is essential.

Qualifications

• Bachelor's Degree in Engineering, Life Sciences, Quality Assurance, Regulatory Affairs, Business Administration, or a related discipline (preferred).
• 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 specifically assigned Quality System processes.
• Provide day-to-day guidance to Quality Systems personnel.
• Support workforce planning, prioritization, and resource coordination.
• Act as the functional escalation point for complex quality and compliance issues as needed.
• Drive consistent application and interpretation of quality procedures and regulatory requirements.
• Support departmental objectives and Quality Management System (QMS) initiatives.
• Lead projects focused on compliance improvements, process optimization, and business effectiveness.
• Provide oversight and guidance for one or more of the Quality System processes as business needs deem necessary.
• Facilitate escalation of systemic product or process issues impacting 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 company procedures
• Participate in regulatory inspections and customer audits.
• Support responses to audit observations and compliance commitments.
• Support in the development and analysis of Quality System performance metrics.
• Support in the monitoring process effectiveness and identify opportunities for improvement.
• Conduct trend analysis to identify emerging compliance risks.
• Utilize data to drive risk-based decision‑making and continuous improvement initiatives.

Skills

Quality Systems

CAPA

Audit & Compliance

Regulatory Affairs

Regulatory Inspections

Documentation

Problem Solving

Project Management

Education

Bachelor's Degree in Engineering / Life Sciences / QA / Regulatory Affairs

Regulatory Affairs Certification (preferred)

Tools

QMS platforms

Job description

BD is seeking a senior Quality Systems professional to lead assigned processes, guide QA teams, and drive regulatory readiness in a fast-paced medical technology environment.

The role focuses on CAPA, Change Control, training, audits, and document control, with responsibility for improving process effectiveness and complying with FDA, GMP, and ISO requirements. Strong collaboration with cross-functional teams is essential.