Job Title: Production Director Location: Jersey City, New Jersey Type: Direct Hire Salary: $120-150k 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 Ref: #558-Scientific System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan. System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.