Site Director - Medical Device

Responsible for the comprehensive management of onsite personnel and plant operational activities. This role encompasses operations, human resources, quality assurance, maintenance, and supply chain. The candidate will develop and drive initiatives to achieve objectives in safety, service, quality, cost, and new product commercialization, fostering an environment of continuous improvement, inclusion, and team commitment to deliver results.

Responsibilities:

Operational Management:

• Lead daily plant operations, ensuring efficiency and continuous improvement.
  
• Remove operational barriers and provide necessary resources to meet objectives.
  

Leadership and Team Development:

• Conduct performance evaluations, coaching, and guidance for employees.
  
• Promote company values and maintain a high-engagement culture.
  
• Develop training plans to align skills with business needs.
  

Strategic Planning:

• Implement and enhance supply chain management and international trade systems (e.g., BASC/OEA).
  

Financial Management:

• Manage budgets, control costs, and maximize profitability.
  
• Oversee financial transactions, including payroll processing.
  

Regulatory Compliance:

• Ensure compliance with GMP, GDP, ISO, FDA, and local regulations.
  

Requirements

Education:

• Bachelor’s degree in Engineering, Business Administration, Business, or related fields.
  
• Master’s degree (preferred).
  

Experience:

• Minimum 10 years in the medical device industry with proven leadership.
  
• Knowledge of sales, marketing, product development, regulatory affairs, and operations.
  
• Experience in financial management (P&L), FDA regulations (510k), ISO 13485, and ERP systems.
  

Key Skills:

• Fluency in English.
  
• Financial acumen (budgeting, accounting, forecasting).
  
• Understanding of the medical device market and its regulatory landscape.
  

Benefits