Principal Quality Engineer - Product Risk & Recalls

Cardinal Health, Inc.; Chihuahua; On-site; MXN 420,000 - 640,000; Full time

Job summary

Cardinal Health, Inc. is seeking a Quality Engineer to lead and influence supplier-driven quality events, recalls, and risk assessments across global sites.

You will collaborate with regulatory, operations, and供应 chain teams to drive corrective actions and ensure patient safety throughout the product lifecycle. The role requires experience in medical device quality systems and strong English communication skills for global stakeholder engagement.

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Industrial Engineering, Life Sciences, Quality, or related technical field preferred.
• 5+ years of experience in Medical Device Quality Engineering, Supplier Quality, Manufacturing Quality, Regulatory Affairs, Product Quality, or related functions preferred.
• Experience supporting recalls, field actions, post-market quality activities, complaint investigations, and product risk assessments preferred.
• Fluent English communication skills (written and verbal) required.
• Ability to lead technical discussions, prepare risk assessments, and communicate effectively with global stakeholders in English.
• Experience working in global, cross-functional environments preferred.

Responsibilities

• Apply advanced quality engineering knowledge and risk management principles to evaluate supplier quality events, recalls, field actions, and nonconforming product notifications.
• Lead end-to-end product impact assessments associated with supplier recalls, safety notices, and quality-related market actions.
• Evaluate impact to finished goods, work-in-process inventory, raw materials, and distribution center inventory.
• Provide technical leadership for pass-through recall determinations, over-labeling activities, product holds, field corrections, and product disposition decisions.
• Conduct and document risk assessments involving patient safety, regulatory compliance, customer impact, and business continuity considerations.
• Develop product bracketing strategies and determine affected products, components, lots, and customer populations.
• Coordinate containment activities with Manufacturing Quality, Supplier Quality, Operations, Distribution Centers, Supply Chain, and Regulatory Affairs.
• Ensure timely implementation and tracking of product holds and inventory containment actions across the Presource network.
• Support escalation, investigation, and resolution of complex supplier quality issues.
• Evaluate the need for Supplier Corrective Action Requests (SCARs) and partner with Supplier Quality on execution and effectiveness monitoring.
• Analyze quality event data and trends to identify opportunities for risk reduction and process improvements.
• May contribute to the development and enhancement of field action, recall management, and risk assessment procedures.
• Develop technical solutions to highly complex quality and compliance challenges that support organizational objectives.
• Lead cross-functional initiatives with multiple stakeholders and functions while operating with a high degree of independence.

Skills

Quality Eng

Risk Mgmt

Regulatory

Cross-functional

Education

Bachelor's degree in Engineering

Job description

Cardinal Health, Inc. is seeking a Quality Engineer to lead and influence supplier-driven quality events, recalls, and risk assessments across global sites.

You will collaborate with regulatory, operations, and供应 chain teams to drive corrective actions and ensure patient safety throughout the product lifecycle. The role requires experience in medical device quality systems and strong English communication skills for global stakeholder engagement.