Senior Quality Engineer — Product Risk & Recalls

Cardinal Health; Ciudad Juárez; Sur place; MXN 300 000 - 600 000; Plein temps

Résumé du poste

Cardinal Health seeks a Quality Engineer to support quality systems across supplier quality, manufacturing, and regulatory affairs. You will evaluate recalls, perform risk assessments, and lead cross-functional efforts to ensure patient safety and regulatory compliance.

The role requires knowledge of FDA QSR (21 CFR 820), ISO 13485, CAPA, and post-market activities, with collaboration across global teams in English.

Qualifications

• Bachelor's degree in Engineering or related technical field preferred.
• 5+ years of experience in Medical Device Quality Engineering or related functions preferred.
• Experience supporting recalls, field actions, post-market quality activities, complaint investigations, and risk assessments.
• Strong knowledge of FDA QSR (21 CFR 820) and ISO 13485, CAPA, and Risk Management.
• Fluent English communication, written and verbal, required.
• Ability to lead technical discussions and communicate with global stakeholders in English.

Responsabilités

• Apply advanced quality engineering knowledge to evaluate supplier quality events, recalls, field actions, and nonconforming notifications.
• Lead end-to-end product impact assessments for supplier recalls and quality actions.
• Evaluate impact to finished goods, WIP, raw materials, and inventory.
• Provide technical leadership for recall determinations, over-labeling, holds, and disposition decisions.
• Conduct risk assessments involving patient safety, regulatory compliance, and business continuity.
• Coordinate containment activities across manufacturing, supplier quality, operations, and regulatory affairs.

Connaissances

Quality Eng

Regulatory Affairs

Risk Management

CAPA

Supplier Quality

English Fluency

Formation

Bachelor's degree in Engineering

Description du poste

Cardinal Health seeks a Quality Engineer to support quality systems across supplier quality, manufacturing, and regulatory affairs. You will evaluate recalls, perform risk assessments, and lead cross-functional efforts to ensure patient safety and regulatory compliance.

The role requires knowledge of FDA QSR (21 CFR 820), ISO 13485, CAPA, and post-market activities, with collaboration across global teams in English.