Manufacturing Director

hace 2 semanas

Tijuana, México TALENT CONNECT EXECUTIVE SEARCH & HR SOLUTIONS A tiempo completo

**Position Summary**We are seeking an experienced Manufacturing Director to lead and optimize our Tijuana-based manufacturing operations for (medical devices / healthcare products / pharmaceuticals). This role is responsible for delivering high-quality products on time, within budget, and in full compliance with FDA, ISO 13485, and Mexican regulatory requirements.**Key Responsibilities****Strategic Leadership**- Develop and execute the manufacturing strategy to support corporate growth objectives.- Lead annual operational planning, capacity expansion, and capital investment projects.- Foster a culture of safety, quality, and continuous improvement across all teams.**Operational Management**- Oversee daily production, maintenance, planning, and warehouse activities.- Ensure compliance with Good Manufacturing Practices (GMP), ISO 13485, and FDA/COFEPRIS requirements.- Manage operational KPIs for on-time delivery, quality yield, cost efficiency, and scrap reduction.**People & Culture**- Lead, coach, and develop plant managers, supervisors, and cross-functional teams.- Drive employee engagement and retention through effective communication, training, and recognition programs.- Promote bilingual/multicultural collaboration across U.S. and Mexico operations.**Quality & Compliance**- Partner with the Quality department to ensure products meet or exceed regulatory and customer expectations.- Support audits from regulatory agencies and customer quality teams.- Maintain all necessary certifications and documentation for medical manufacturing compliance.**Cross-Border & Cross-Functional Collaboration**- Coordinate closely with U.S. headquarters on production forecasts, new product introductions, and operational updates.- Collaborate with engineering, supply chain, and R&D teams for process improvements and technology transfers.- Ensure smooth communication and workflow between facilities across the border.**Qualifications**- Bachelor’s degree in Engineering, Industrial Engineering, Manufacturing, or related field (Master’s preferred).- 10+ years of progressive manufacturing leadership experience, with at least 5 years in the medical device, pharmaceutical, or other highly regulated industry.- Proven success in lean manufacturing, Six Sigma, and operational excellence initiatives.- Strong understanding of FDA, ISO 13485, GMP, and COFEPRIS requirements.- Experience managing operations in Mexico, preferably within the Tijuana maquiladora sector.- Bilingual - fluent in English and Spanish (written and verbal).- Strong financial and analytical skills for managing budgets, cost control, and ROI analysis.**Key Competencies**- Strategic vision with hands-on leadership style- Exceptional communication and negotiation skills- Ability to influence across cultural and organizational boundaries- Data-driven decision-making- Commitment to safety, quality, and ethical practices

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