**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 *****, 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.

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