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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. The ideal candidate is a bilingual (English/Spanish) operational leader with a proven track record in lean manufacturing, cross-border team management, and regulated industry compliance. 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 #J-18808-Ljbffr
