Quality Engineering Lead

Cardinal Health; El Paso (TX); On-site; USD 71,000 - 99,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Access to wages before pay day with my

Job summary

Cardinal Health seeks a Quality Engineer to develop and implement quality policies, procedures, and processes ensuring compliance with ISO 13485 and FDA standards. You will manage quality planning, evaluation, and control across cross-functional teams and drive CAPA and audit programs.

The role requires 4–8 years of relevant experience, knowledge of regulatory requirements, and strong document control. You will collaborate with Operations, Maintenance and Engineering to meet regulatory and

Qualifications

• 4–8 years of experience, bachelor’s degree preferred or equivalent work experience.
• Knowledge with ISO 13485 and FDA; document control.
• Preferred Experience in Internal Audits.
• Preferred Participation in CAPA System.
• Preferred Knowledge Quality system Regulations ISO 13485 and FDA.
• Preferred Knowledge Document Control.

Responsibilities

• Develop and implement quality policies, procedures, and processes to ensure products and services comply with regulatory standards, specifications and corporate procedures.
• Manage product and service quality planning, evaluation, process control, records, and document changes.
• Works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.
• Responsible to manage their direct reports and staff to achieve quality goals and maintain regulatory compliance.
• Works with multiple QMS systems for data and record management to maintain regulatory compliance.
• Coordinate and lead actions for regulatory, customer and corporate audits and customer technical visits.
• Engage with Operations, Maintenance and Engineering to achieve site savings goals.
• Defect Training - Visual Aids.
• Coordinate and supervise daily activities of operations or business staff.
• Administers and exercises policies and procedures.
• Ensures employees operate within guidelines.
• Decisions have a direct impact to work unit operations and customers.
• Frequently interacts with subordinates, customers, and peer groups at various management levels.

Skills

Quality regulations (ISO 13485, FDA)

Document Control

Internal Audits

CAPA system experience

Regulatory compliance

Education

Bachelor’s degree in related field

Tools

Quality Management System (QMS)

CAPA Software

Job description

Cardinal Health seeks a Quality Engineer to develop and implement quality policies, procedures, and processes ensuring compliance with ISO 13485 and FDA standards. You will manage quality planning, evaluation, and control across cross-functional teams and drive CAPA and audit programs.

The role requires 4–8 years of relevant experience, knowledge of regulatory requirements, and strong document control. You will collaborate with Operations, Maintenance and Engineering to meet regulatory and