Manufacturing Manager - Medical Devices

Talent Connect Now; Tijuana; Presencial; MXN 1,260,000 - 1,621,000; Jornada completa

Descripción de la vacante

A leading manufacturing organization in Tijuana seeks a Production Manager to oversee daily operations, manage production scheduling, and ensure compliance with FDA standards. The ideal candidate will have 5+ years of experience in medical device manufacturing management, a degree in a relevant field, and a strong knowledge of Lean Manufacturing and Six Sigma principles. This role also involves leading and developing production staff, driving continuous improvement initiatives, and collaborating with quality teams.

Formación

• 5+ years of experience in medical device manufacturing management.
• Strong knowledge of FDA 21 CFR Part 820, ISO, and Lean Manufacturing principles.
• Proven ability to lead large production teams and drive efficiency.

Responsabilidades

• Oversee daily manufacturing operations to meet production goals.
• Implement and drive Lean Manufacturing and Six Sigma initiatives.
• Manage production scheduling and workforce planning.
• Ensure compliance with medical device industry standards.
• Lead root cause analysis for production issues.

Conocimientos

Leadership

Problem-solving

Team development

Lean Manufacturing

Regulatory compliance

Educación

Bachelor's degree in Engineering, Manufacturing, or related field

Herramientas

Lean Manufacturing

Six Sigma

Manufacturing KPIs

Descripción del empleo

Job Summary

Oversee daily manufacturing operations, ensuring production goals are met while maintaining safety and quality. Implement Lean Manufacturing, Six Sigma, and continuous improvement initiatives to optimize efficiency and reduce waste.

Production Management & Efficiency :

• Oversee daily manufacturing operations , ensuring production goals are met while maintaining safety and quality.
• Implement and drive Lean Manufacturing, Six Sigma, and continuous improvement initiatives to optimize efficiency and reduce waste.
• Ensure compliance with FDA 21 CFR Part 820, ISO , and GMP regulations in all manufacturing processes.
• Manage production scheduling, resource allocation, and workforce planning to meet business objectives.

Quality & Regulatory Compliance :

• Work closely with Quality Assurance and Regulatory teams to ensure all products meet strict medical device industry standards.
• Lead root cause analysis and corrective / preventive action (CAPA) for production issues.
• Monitor and analyze manufacturing KPIs , ensuring continuous process improvements.

Leadership & Team Development :

• Lead and develop manufacturing supervisors and production staff , fostering a culture of accountability and operational excellence.
• Ensure proper training, mentorship, and compliance with company policies and regulatory requirements.
• Drive cross-functional collaboration with engineering, supply chain, and quality teams to optimize production strategies.

Qualifications & Experience :

• Bachelor's degree in Engineering, Manufacturing, Industrial Engineering, or a related field.
• 5+ years of experience in medical device manufacturing management .
• Strong knowledge of FDA 21 CFR Part 820, ISO , and Lean Manufacturing principles .
• Experience in high-volume manufacturing and automation processes preferred.
• Proven ability to lead large production teams , drive efficiency, and improve operational performance.
• Excellent problem-solving, communication, and organizational skills.