Quality Engineering Lead - Audits, CAPA & Compliance

Cardinal Health, Inc.; El Paso (TX); On-site; USD 71,000 - 102,000; Full time

Job summary

Cardinal Health, Inc. is seeking a Quality Engineer to develop and implement quality policies, procedures, and processes to ensure regulatory compliance across products and services.

This role partners with Operations, Maintenance and Engineering to achieve site savings and uphold ISO 13485 and FDA requirements. You will supervise staff, manage audits, CAPA activities, and document control within multiple QMS systems, contributing to continuous improvement and customer trust.

Qualifications

• 4–8 years of experience in quality engineering or related field.
• Bachelor’s degree in a related field preferred or equivalent work experience.
• Knowledge of ISO 13485 and FDA quality system regulations.
• Experience with document control processes.
• Experience in internal audits.
• Experience with CAPA systems.

Responsibilities

• Develop and implement quality policies, procedures, and processes to ensure compliance.
• Manage product and service quality planning, evaluation, and control.
• Supervise staff to achieve quality goals and regulatory compliance.
• Work with multiple QMS systems for data and record management.
• Coordinate and lead regulatory, customer, and internal audits.
• Collaborate with Operations, Maintenance and Engineering to achieve site savings.
• Defect training and visual aids.

Skills

Quality systems knowledge

Internal audits

CAPA

Regulatory compliance

Document control

Cross-functional collaboration

Education

Bachelor's degree in related field

Tools

QMS systems

Job description

Cardinal Health, Inc. is seeking a Quality Engineer to develop and implement quality policies, procedures, and processes to ensure regulatory compliance across products and services.

This role partners with Operations, Maintenance and Engineering to achieve site savings and uphold ISO 13485 and FDA requirements. You will supervise staff, manage audits, CAPA activities, and document control within multiple QMS systems, contributing to continuous improvement and customer trust.