Job Summary : * Key Responsibilities : 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 13485, 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 13485, 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.

📌 Manufacturing Manager - Medical Devices (Tijuana)
🏢 Talent Connect Now
📍 Tijuana