Manufacturing Director

Position Overview

The Manufacturing Director provides strategic leadership of all production operations in a medical device facility, ensuring compliance with FDA, ISO 13485, and GMP. This role drives operational excellence, continuous improvement, and long-term growth, while overseeing three primary direct reports: Production Manager, Operations Manager, and Engineer.

Key Responsibilities

• Lead and develop direct reports and the manufacturing team to foster a culture of safety, quality, and accountability.
• Define and execute long-term manufacturing strategies aligned with corporate goals and regulatory requirements.
• Ensure full compliance with FDA, ISO 13485, GMP, and internal quality systems.
• Drive Lean, Six Sigma, and continuous improvement initiatives to optimize efficiency and reduce costs.
• Oversee equipment qualification/validation (IQ, OQ, PQ) and maintenance programs.
• Collaborate with Quality, Supply Chain, Engineering, and R&D on new product launches and process scaling.
• Manage budgets, capital investments, and operational KPIs, report performance to executive leadership.
• Lead audits, CAPA initiatives, and risk management programs.
• Plan all productions according to the business unit requirements and forecast.
• Manage direct relationship with supplier, optimize costs, supply chain.

Qualifications

• Bachelors in Manufacturing, Engineering, or related field (Master’s preferred).
• 10+ years in manufacturing, with 5+ years in a director-level role in medical device or regulated manufacturing. Experience in Cosmetic products manufacturing is a plus.
• Deep knowledge of FDA, ISO 13485, GMP, and quality systems.
• Experience with Lean, Six Sigma, ERP/MRP systems, and strategic planning.
• Proven leadership, cross-functional collaboration, and performance management skills.

Core Competencies

• Strategic manufacturing leadership & operational excellence
• Regulatory compliance & quality focus
• Continuous improvement & process optimization
• Talent development & team leadership
• Financial management & KPI reporting