Job Description Summary

To develop and document Quality plans and procedures as required. Prevent and resolve Quality problems. Improve areas of high-quality costs. Represent quality interests and concerns on project teams. Conduct root cause analysis and investigation for customer complaints and non-conformance product. Ensure compliance with Corporate, ISO, FDA, and Local standards requirements.

Job Description

About of BD

Our talent and culture philosophy focuses on making our people the greatest competitive advantage.

BD es una de las compañías de tecnología médica más grandes del mundo. Tenemos una posición única en el mercado con soluciones para mejorar el manejo de la enfermedad y el manejo de la atención, apoyando a clientes, profesionales de la salud y pacientes en la mejora de la práctica clínica. A nivel mundial, somos más de 65,000 empleados apasionados por lo que hacemos y estamos comprometidos a impulsar el mundo de la salud con soluciones desde el diagnóstico hasta el tratamiento.

¡Únete a nosotros!

Job Summary

To develop and document Quality plans and procedures as required. Prevent and resolve Quality problems. Improve areas of high-quality costs. Represent quality interests and concerns on project teams. Conduct root cause analysis and investigation for customer complaints and non-conformance product. Ensure compliance with Corporate, ISO, FDA, and Local standards requirements.

Job Responsibilities

• Provide technical support to resolve quality problems in development, pilot, manufacturing
• Design and conduct quality engineering studies to determine causes of quality nonconformances, initiate changes in process, tooling, etc., to correct them.
• Make dispositions of rejected nonconforming products’ conduct MRB action when required.
• Organize and generate detailed quality information reports to engineering, manufacturing, and management.
• Provide documented instructions for performance of QC inspections, including QC plans, inspection and test procedures, and quality Standards.
• Exercise control over the quality of conformance of the products generated in his area\Design and qualify inspection and test equipment.
• The QA Engineer has the authority to develop and document plans in order to prevent and resolve quality issues. Additionally, has the authority to put product on hold and release product as per applicable procedures.
• Lead and guide peers and direct-reporting personnel, on how to conduct the Nonconformance process (NC).
• Development of Test Methods.
• Development of Control Plans.
• Approve/support validations protocols (Software/IQs/OPs/PQs) if applicable.

Education

• Bachelor’s degree in technical sciences or Engineering.

Knowledge & Skills

• Minimum 3 years’ experience in Quality/Manufacturing or Engineering positions.
• Knowledge on International Regulations and Standards (i.e., ISO-13485, FDA, etc.).
• Knowledge on Quality Tools and statistical techniques. (Control charts, sampling plans, Design of experiments, etc.).
• Knowledge on Quality systems.
• Communication, Reports, Data analysis.
• Root cause analysis techniques.
• Ability to communicate in English (Oral and written) fluently.
• Certified as Quality Engineer (Preferable).

Required Skills

Optional Skills

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Primary Work Location

MEX Juarez Homecare

Additional Locations

Work Shift