Senior Quality Engineer: Product Risk & Recalls Lead

Cardinal Health; Chihuahua; On-site; MXN 420,000 - 660,000; Full time

Job summary

Cardinal Health is seeking a Quality Engineer to lead supplier quality events, recalls, risk assessments, and cross-functional quality initiatives. You will drive end-to-end evaluations, containment actions, and regulatory compliance across the product lifecycle.

The role requires strong English communication, collaboration with global teams, and expertise in quality systems and CAPA within a medical device context.

Qualifications

• Bachelor's degree in Engineering or related technical field.
• 5+ years in Medical Device Quality Engineering or related functions.
• Experience supporting recalls, field actions, and risk assessments.

Responsibilities

• Lead evaluation of supplier quality events, recalls, and nonconforming products.
• Oversee end-to-end product impact assessments for recalls and field actions.
• Evaluate impact to finished goods, WIP, raw materials, and distribution inventory.
• Provide technical leadership for product holds, field corrections, and dispositions.
• Conduct risk assessments covering patient safety, regulatory compliance, and business continuity.
• Collaborate across Manufacturing, Supplier Quality, Regulatory Affairs, and Supply Chain.

Skills

Quality Engineering

Risk Management

Regulatory Affairs

English proficiency

Education

Bachelor's degree in Engineering

Tools

CAPA Software

QMS Software

Risk Analysis Tools

Job description

Cardinal Health is seeking a Quality Engineer to lead supplier quality events, recalls, risk assessments, and cross-functional quality initiatives. You will drive end-to-end evaluations, containment actions, and regulatory compliance across the product lifecycle.

The role requires strong English communication, collaboration with global teams, and expertise in quality systems and CAPA within a medical device context.