- Responsible for Manufacturing Operations includes Management of all Manufacturing Personnel.
- Ensures through behavior and action a safe working environment for all employees.
- Ensures all established cost, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards.
- Responsible for driving efficiency improvements and compliance by achieving established Operational KPI Targets (i.e. OEE%)
- Lead Lean Culture and team engagement while coordinating all Kaizen Events – Achieve Lean Targets.
- Drive the implementation of 6S, MDI, Visual Factory, and Standard of Work in Manufacturing Areas.
- Works with Supply Chain to achieves Schedule Compliance and Execution to support Inventory & Build Plan Targets.
- Supports the Quality System to achieve Quality KPI’s. Includes NC, CAPA, and DCR support.
- Helps to develop, maintain and improve as necessary the documentation system for Bill of Materials, Routers, and other documents as required in accordance with GMP’s. Ensure associates are trained and compliant with procedures and instructions.
- Optimize equipment utilization by prioritizing Predictive/Preventative Maintenance Activities
- Establishes priorities and sequences for manufacturing products in accordance with Production Schedule in a very dynamic environment.
- Schedules production floor equipment and operators in tandem with Supervisors.
- Maintain positive employee morale and address employee issues in cooperation with HR.
- Leads Employee Engagement Action Plan for the site.
- Ensures Manufacturing Areas are organized Properly and Maintain Housekeeping Standards.
- Work with HR to ensure employees are hired, retained, trained, and developed, and temporary staffing needs are properly met while maintaining low turn-over at the site.
- Provides leadership and support to the NPI process to achieve the flawless launch of new products and processes into Manufacturing.
- Participates in development of manufacturing processes including personnel requirements, material needs, facility needs, tooling and equipment needs and plans.
- Establishes manufacturing and quality standards, process controls, develops budget and cost controls, forecasts capacity/utilization, evaluate trends, and obtains data regarding types, quantities, specifications, and delivery dates of products ordered/scheduled.
- Coordinates activities with all other functions of the organization to obtain optimum production and utilization of human resources, machines, and equipment.
- Reviews production and operating reports and directs the resolution of manufacturing, and maintenance problems to ensure minimum costs and prevent operational delays.
- Supports Budget and Physical Inventory Processes
- Performs administrative activities and attends all meetings as required.
- Trains and ensures all assigned employees are aware of and comply with company, government procedures, and regulations.
- Responsibilities include appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Maintains presence in Clean Room to support employees as required.
- Manage other duties as assigned.
What are we looking for?
- Bachelor’s Degree in Engineering, Science or relevant field.
- Minimum of ten (10) professional experience in a Manufacturing Management role within a medical device or pharmaceutical manufacturing environment.
- Minimum Lean Green Belt Certification; Lean Black Belt Certification a plus
- Experience utilizing KPI’s to drive performance
- Servant Leadership Style
- Exceptional communication, attention to detail, and follow-up skills
- Demonstrated knowledge of FDA regulations and other National and International regulations and standards.
- Demonstrated computer skills.
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