Manufacturing Director Job at System One in Jersey City

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 #J-18808-Ljbffr