Quality System Specialist

Baxter International Inc.; Valle de Chalco Solidaridad; Presencial; USD 25,000 - 35,000; Jornada completa

Descripción de la vacante

A leading company in the medical field is seeking a Quality System Specialist to maintain Supplier Quality Systems and ensure compliance with global policies. The role involves training, project management, and continuous improvement initiatives to enhance supplier quality across the Americas.

Formación

• 5 to 8 years of experience in Quality Systems, preferably in Supplier Quality.
• Knowledge of international standards ISO 9001 / ISO 13485.

Responsabilidades

• Ensure compliance with Supplier Quality subsystems according to Global Policies.
• Coordinate training and access to SQLM for all users in Latin America.

Conocimientos

Trend analysis

Project management

Educación

Degree in Biochemical Engineering

QFB

Descripción del empleo

Aquí es donde salvas y sostienes vidas

En Baxter, estamos profundamente conectados por nuestra misión. No importa tu rol en Baxter, tu trabajo tiene un impacto positivo en la gente alrededor del mundo. Sentirás un propósito en toda la organización, ya que sabemos que nuestro trabajo mejora los resultados para millones de pacientes.

Los productos y terapias de Baxter se encuentran en casi cada hospital del mundo, en clínicas y en los hogares. Por más de 85 años, hemos sido pioneros en innovaciones médicas que transforman el cuidado en salud.

Juntos creamos un lugar donde somos felices, exitosos y nos inspiramos mutuamente. Aquí es donde puedes hacer tu mejor trabajo.

Únete a nosotros en la intersección de salvar y sostener vidas, donde tu propósito acelera nuestra misión.

Join an organization and a team where your work matters. Join us now!

Your role at Baxter

As a Quality System Specialist, you will effectively maintain the Supplier Quality System (SQLM-TW), uphold the Quality Policies of Supplier Quality in the Americas, establish a system of continuous improvement through ongoing evaluations of current processes and activities/needs in each Americas location, and support activities related to Supplier Quality Global on topics such as SQ and Opex (Operational Excellence), including Metrics and SQLM-TW, involving the Supplier Quality System.

What you'll be doing

• Ensure the implementation and compliance of the Supplier Quality subsystems according to Global Policies, meeting all deadlines. This includes: Supplier Evaluation and Selection, Maintenance of existing suppliers, Supplier Complaints (SCAR), Supplier Audits, Supplier Action and Risk Mitigation Plans (RAM), Supplier Change Notifications, and Supplier Terminations.
• Maintain and manage the NSR (New Supplier Requests) system for all suppliers in the Americas.
• Ensure compliance with and manage Regional and Global Metrics.
• Coordinate training and access to SQLM for all Latin American and Caribbean users. Conduct Regional Train-the-Trainer sessions for the Supplier Quality process.
• Serve as Regional SME (Subject Matter Expert) for Global Supplier Quality processes.
• Ensure compliance with applicable BPDs and SOPs.
• Perform SQLM-TW system maintenance activities related to SQ Opex.

What you'll bring

• Degree in Biochemical Engineering, QFB, or related fields.
• 5 to 8 years of experience in Quality Systems, preferably in Supplier Quality.
• Knowledge of international standards ISO 9001 / ISO 13485.
• Trend analysis skills.
• Project management skills to handle multiple issues of moderate to high complexity independently with minimal supervision.
• Experience in a medical device, pharmaceutical, or highly regulated environment is a plus.
• Knowledge and experience with Quality Management Systems, GMPs, regulatory guidelines, and statistics are preferred.

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Adaptaciones razonables

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