_What QRA Management contributes to Cardinal Health_

QRA Management is responsible for strategic oversight and leadership direction over multiple job families or areas of expertise within the QRA function.
- Demonstrates understanding of quality philosophies, principles, systems, methods, tools, and standards.
- Develops and implements quality programs and process improvement initiatives to ensure compliance of final product quality standards and delivery.
- Applies problem solving and quality improvement tools and techniques, including, preventive and corrective actions and how to overcome barriers to quality improvements.
- Acquires and analyzes data using appropriate standard quantitative, statistical methods to facilitate process analysis and improvements.
- Understands product design, design transfers, and production line quality standards, i.e., controls, process quality in accordance with quality principles, which include planning processes, design control, material control, acceptance sampling and measurement systems.
- Demonstrates knowledge of reliability, maintainability,



and product risk management, including key terms and definitions, modeling, systems design, assessment tools and reporting.
- Experience with performing process validations (IQ/OQ/PQ), equipment qualification, and test method validations.
- Strong communication skills (written and verbal); ability to present communication plans and status updates to customers.

_ Qualifications_
- Bachelor’s Degree in Engineering, related field, or equivalent work experience in focused area.
- 8+ years QRA experience in related field within medical device environment
- Advance English and Spanish (read, write, speak)
- Solid leadership and mentorship experience
- Proven experience within a medical device manufacturing environment (ISO13485)
- Demonstrated knowledge of medical device and governmental regulations and standards (21 CFR Part 820, ISO13485, MDR).
- Knowledge and experience of medical device

📌 Gerente de Calidad (Ciudad Juárez)
🏢 Cardinal Health
📍 Ciudad Juárez