Quality Engineering Leader: ISO/FDA Compliance

RXinsider LTD.; El Paso (TX); On-site; USD 71,000 - 102,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off

Health savings account

401k savings plan

Wages access before payday

FSAs

Disability coverage

Work-Life resources

Paid parental leave

Healthy lifestyle programs

Job summary

Cardinal Health is seeking 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 cross-functional activities while leading CAPA and internal audits.

You will supervise staff, coordinate audits, and collaborate with Operations, Maintenance and Engineering to meet site savings goals. Strong documentation control and regulatory knowledge are essential.

Qualifications

• 4–8 years of experience, preferred
• Bachelor’s degree in related field, preferred or equivalent work experience
• Knowledge with ISO 13485 and FDA quality system regulations, and document control, preferred
• Experience in Internal Audits, preferred
• Participation in CAPA System, preferred
• Knowledge Quality system Regulations ISO 13485 and FDA, preferred

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; work cross-functionally in prevention-based methodologies
• Manage direct reports and staff to achieve quality goals and maintain regulatory compliance
• Work 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

Skills

Quality systems knowledge

Internal audits

CAPA process

Document control

Education

Bachelor's degree

Job description

Cardinal Health is seeking 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 cross-functional activities while leading CAPA and internal audits.

You will supervise staff, coordinate audits, and collaborate with Operations, Maintenance and Engineering to meet site savings goals. Strong documentation control and regulatory knowledge are essential.