Job Title: Production Director
Location: Jersey City, New Jersey
Type: Direct Hire
Salary: $120-150k
Position OverviewThe 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
