Production Supervisor, Manufacturing

Enable Injections Inc.•Sharonville, OH

2d•Onsite

About The Position

The Production Supervisor oversees manufacturing operations for medical devices in a cleanroom environment. The role directs and develops manufacturing assembly technicians, maintains production schedules, and ensures products, documentation, equipment, and cleanroom operations comply with Enable Injections procedures, Good Manufacturing Practices, and FDA regulations. The supervisor reviews daily production paperwork, completes SAP transactions, manages materials and inventory, and identifies and escalates deviations and operational risks. The position also leads hiring, training, performance reviews, and process-improvement efforts while coordinating communication across shifts and departments.

Requirements

High school diploma or GED.
Ability to read and write in English.
At least five years of production experience in a manufacturing cleanroom environment.
Demonstrated positive leadership and ability to train and develop hourly employees on a manufacturing floor.
Ability to handle multiple tasks and priorities in a changing environment while maintaining professionalism and calm under pressure.
Self-starter able to work with little to no supervision and prioritize the team’s work without day-to-day direction.
Highly detail-oriented, with the ability to detect abnormal product, paperwork, and equipment issues.
Experience and confidence working with and troubleshooting high-speed automation and advanced robotics.
Exceptional communication and interpersonal skills when interacting with direct reports, other shifts, department management, and other employees.
General manufacturing-floor computer skills, including Microsoft Office Suite and ERP and time-management systems.

Nice To Haves

Experience in medical-device manufacturing or pharmaceutical manufacturing.
Prior leadership experience in a high-speed manufacturing environment.
Prior leadership experience in an FDA-regulated environment.
Bachelor of Science degree in Business, Engineering, or a related field.

Responsibilities

Review daily production paperwork in real time, complete daily SAP transactions, identify procedural deviations immediately, and create or complete product non-conformity reports and CAPAs as needed.
Plan and maintain schedules; direct employee work; manage training requirements; and provide direction, coaching, counseling, and leadership to improve performance and service quality.
Ensure medical-device production complies with Enable Injections Standard Operating Procedures, Good Manufacturing Practices, and FDA regulations.
Ensure production documentation is complete and accurate each day.
Escalate operational details and planning risks to the Manufacturing Manager as needed to support production planning and organizational initiatives.
Ensure the cleanroom and equipment are operated, maintained, and cleaned in compliance with governing procedures.
Lead hiring, training, and scheduling for manufacturing assembly technicians.
Complete performance reviews and provide consistent ongoing feedback to manufacturing assembly technicians.
Monitor equipment performance and product scrap, and escalate abnormal issues.
Ensure equipment repairs, modifications, adjustments, and preventive maintenance are properly documented and reported, and that equipment meets procedural requirements before use.
Manage requisition and consumption of raw materials and receipt of finished goods into inventory, accurately accounting for scrap and labor in SAP.
Initiate, lead, and author SOP document changes in Enable Injections’ controlled document management system.
Identify and champion process improvements in manufacturing.
Manage employee time and attendance and hold employees accountable for attendance and punctuality expectations.
Support other departments with administrative and other issues as needed.
Ensure timely and accurate communication across shifts and departments.