Principal Quality Engineer, Product Risk Management

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

Principal Quality Engineer, Product Risk Management### Principal Quality Engineer, Product Risk ManagementApply: In-Person: Mexico-Juarez Presource: Full time: Posted Today: 20188076**What Quality Engineering contributes to Cardinal Health**Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with applicable regulatory standards and specifications.Quality Engineering manages product and service quality planning, evaluation, control, and continuous improvement activities. This job family works cross-functionally to identify, assess, and mitigate quality risks affecting products throughout their lifecycle while ensuring compliance, patient safety, and business continuity. **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.**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.* Strong knowledge of FDA Quality System Regulations (21 CFR Part 820 / QMSR), ISO 13485, CAPA, Supplier Quality Systems, Risk Management, and Medical Device Quality Systems 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.**What is Expected of You and Others at This Level*** Applies comprehensive knowledge and a thorough understanding of quality engineering concepts, regulatory requirements, and risk-based decision-making principles.* Serves as a technical subject matter expert for supplier-driven quality events, recalls, field actions, and product risk assessments.* Works on highly complex, cross-functional projects with significant quality, regulatory, operational, and business impact.* Develops innovative technical solutions to a wide range of difficult quality and compliance issues.* Influences decisions across Quality, Operations, Regulatory Affairs, Supply Chain, Distribution, and Supplier Quality organizations.* Operates independently with minimal direction while providing recommendations to senior leadership.* May mentor and provide technical guidance to less experienced engineers and quality professionals.* Leads enterprise-level quality initiatives affecting multiple manufacturing sites, supplier networks, and distribution locations.* Demonstrates strong verbal and written communication skills and effectively presents technical assessments, recommendations, and quality event status to leadership and cross-functional partners.* Effectively communicates and collaborates in English across global Quality, Regulatory, Operations, Supply Chain, Supplier Quality, and Commercial organizations.* Provides technical ownership for quality event management processes supporting business continuity, compliance, and patient safety.Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.