Senior Quality Engineer, Product Risk & Compliance

Cardinal Health; Ciudad Juárez; On-site; MXN 900,000 - 1,300,000; Full time

Job summary

Cardinal Health in Juárez, Mexico seeks a Principal Quality Engineer for Product Risk Management to lead risk assessments, supplier quality events, and end-to-end recalls with cross-functional teams across Manufacturing Quality, Regulatory Affairs, and Supply Chain.

You will develop strategies for field actions, product holds, and disposition decisions, ensure compliance with FDA QSR and ISO 13485, and mentor engineers while communicating in English with global stakeholders.

Qualifications

• Bachelor's degree in Engineering or a related technical field.
• 5+ years in Medical Device Quality Engineering or related functions.
• Experience supporting recalls, field actions, post-market activities.
• Strong knowledge of FDA QSR (21 CFR Part 820) and ISO 13485.
• Fluent English communication, both written and spoken.
• Ability to lead discussions and communicate with global stakeholders.

Responsibilities

• Lead end-to-end product impact assessments for recalls and field actions.
• Evaluate impact to finished goods, work-in-process, raw materials, and inventory.
• Provide technical leadership for product holds and disposition decisions.
• Conduct risk assessments involving patient safety and regulatory compliance.
• Coordinate containment actions with Manufacturing, Regulatory, Supply Chain, and Quality.
• Develop risk-based strategies and communicate with cross-functional teams.
• Mentor engineers and lead enterprise-wide quality initiatives.

Skills

Quality engineering

Risk management

Regulatory knowledge

English communication

Cross-functional collaboration

Education

Bachelor's degree in Engineering or related field

Tools

CAPA system

SCARs

Quality Management Systems

Post-market surveillance

Job description

Cardinal Health in Juárez, Mexico seeks a Principal Quality Engineer for Product Risk Management to lead risk assessments, supplier quality events, and end-to-end recalls with cross-functional teams across Manufacturing Quality, Regulatory Affairs, and Supply Chain.

You will develop strategies for field actions, product holds, and disposition decisions, ensure compliance with FDA QSR and ISO 13485, and mentor engineers while communicating in English with global stakeholders.