Líder de Quejas y Análisis de Fallas en MedTech

BD Mexico; Tijuana; Presencial; MXN 900.000 - 1.500.000; Jornada completa

Descripción de la vacante

BD Mexico in Tijuana is seeking an experienced Failure Investigation Leader to ensure regulatory-compliant documentation, lead a team of analysts, and drive root-cause analysis for infusion pumps.

The role emphasizes implementing efficient investigation processes, supporting audits, and coordinating with global service operations, with advanced English and a university degree in engineering.

Formación

• Bachelor's degree in engineering or related field is mandatory.
• Advanced conversational English.
• Experience in the medical device industry preferred.
• Experience leading a failure investigation team.
• History of identifying root causes in electromechanical devices.
• Knowledge of inspection/test protocols for complex electromechanical equipment preferred.
• Demonstrated ability to implement new failure investigation processes and test protocols.
• Six Sigma Green Belt certification preferred.

Responsabilidades

• Ensure documentation and records of investigation and failure analysis meet regulatory requirements.
• Participate in internal and external audits and inspections as needed.
• Perform project management tasks, resource assessment, presentations, and strategic planning.
• Implement processes to handle high volume of incoming complaints through client-informed events and global service activities.
• Identify and implement efficiency improvements in failure analysis processes; participate in external regulatory inspections.
• Oversee pre- and post-inspection activities including records review, training, logistics.
• Provide guidance to the failure analysis team to ensure best practices are used in investigations of infusion pumps.

Conocimientos

Advanced English

Team leadership

Root cause analysis

Failure analysis

Process improvement

Educación

Bachelor's degree in Engineering or related field

Herramientas

Six Sigma Green Belt

Descripción del empleo

BD Mexico in Tijuana is seeking an experienced Failure Investigation Leader to ensure regulatory-compliant documentation, lead a team of analysts, and drive root-cause analysis for infusion pumps.

The role emphasizes implementing efficient investigation processes, supporting audits, and coordinating with global service operations, with advanced English and a university degree in engineering.