**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

📌 Manufacturing Director - Medical Industry (Tijuana)
🏢 Talent Connect Now
📍 Tijuana