Ingeniero de Calidad

Cardinal Health Canada Inc.; Nuevo León; Hybrid; MXN 320,000 - 520,000; Full time

Job summary

Cardinal Health in Juarez seeks a Senior Specialist, Quality Assurance to support quality programs and regulatory compliance. You will mentor junior specialists, assist with SOP development, and lead root-cause analyses to mitigate recalls and customer complaints.

With 2–4 years of QA experience and a related Bachelor's degree, you will work under the Manager to strengthen quality audits, document processes, and ensure regulatory readiness across distribution centers in the region.

Qualifications

• 2–4 years of experience in quality assurance.
• Bachelor's degree in related field or equivalent work experience.
• Experience with recalls and customer complaints preferred.

Responsibilities

• Ensures fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls.
• Executes internal programs to define Quality guidelines and track adherence to these guidelines.
• Provides guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements.
• Responds to significant quality issues and, in support of the Manager, conducts root cause analyses, reports on relevant quality metrics and trends, and develops insights.
• Collaborates with Quality Assurance Specialists in other specialty areas to develop recommendations.
• Supports the Change Control Program by assessing QA implications and impacts of operational and product changes.
• Updates standard operating procedures in response to product changes and regulatory developments under the guidance of the Manager.
• Prepares responses to regulatory queries, regulatory audits, and corporate audits and gathers necessary information from products and operations stakeholders.
• Supports the Manager in quality audits and inspections of distribution centers within the region.
• Mentors junior Specialists and assists with onboarding trainings.

Skills

Quality Assurance

Regulatory compliance

Root cause analysis

SOP development

Cross-functional collaboration

Education

Bachelor's degree

Job description

Ingeniero de Calidad### Ingeniero de CalidadApply: In-Person: Mexico-Juarez Presource: Full time: Posted Today: 20189430***What Quality Assurance contributes to Cardinal Health*** Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant and cost effective quality system that assures products and services are reliable, safe and effective. This job family provides oversight of production/manufacturing activities, training to operational and quality control personnel, and educates business leaders on Quality policies and procedures and ensures that all products and services are properly reviewed for quality and documented. ***Job Summary*** The Senior Specialist, Quality Assurance executes quality programs, policies, and procedures in a particular area of specialty (such as recalls and customer complaints) in order to minimize risks and drive supply chain integrity. Applying knowledge of quality assurance concepts and technical capabilities, the Senior Specialist supports the Manager, Quality Assurance in quality audits and develops actionable insights and recommendations for addressing complex quality issues. Due a higher level of experience and knowledge, the Senior Specialist mentors junior Specialists and, under the guidance of the Manager, may lead the development of standard operating procedures in assigned specialized area. ***Responsibilities*** * Ensures fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls. Submits reports for internal review prior to submission to regulatory bodies.* Executes internal programs to define Quality guidelines and track adherence to these guidelines. Provides guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements.* Responds to significant quality issues and in support of the Manager, conducts root cause analyses, reports on relevant quality metrics and trends, and develops insights for internal stakeholders. Collaborates with Quality Assurance Specialists in other specialty areas as necessary to develop recommendations.* Supports of the Change Control Program, by assessing Quality Assurance implications and impacts of operational and product changes, with a focus on specialty area.* Updates standard operating procedures in response to product changes and regulatory developments under the general guidance of the Manager. Resolutions to significant quality issues, such as recalls or customer complaints, may set precedent for updates to SOPs.* Prepares responses to regulatory queries, regulatory audits, and corporate audits and gathers necessary information from products and operations stakeholders.* Supports the Manager, Quality Assurance in quality audits and inspections of distribution centers within the region. Records quality issues and provides draft reports and insights to the Manager, for delivery to the Operations stakeholders.* Provides guidance to junior level Specialists on complex issues, assists with onboarding trainings, and frequently reviews the work of Specialists prior to delivery to a Manager. ***Qualifications**** 2-4 years of experience, preferred* Bachelor's degree in related field, or equivalent work experience, preferred ***What is expected of you and others at this level**** Applies working knowledge in the application of concepts, principles and technical capabilities to perform varied tasks* Works on projects of moderate scope and complexity* Identifies possible solutions to a variety of technical problems and takes action to resolve* Applies judgment within defined parameters* Receives general guidance and may receive more detailed instruction on new projects* Work reviewed for sound reasoning and accuracyCardinal 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.