Manufacturing Team Leader / Packaging and Maintenance Technician

Job Summary

As the Manufacturing Team Leader, the responsibility is to direct the final assembly of products. In this capacity, the Manufacturing Team Leader directs and coordinates the activities of the Assemblers who are often less experienced. As the Packaging & Maintenance Technician, being responsible for operating automated packaging machinery and performing routine, preventative, and corrective maintenance on production equipment. This role ensures that medical diagnostic products are securely packaged to meet strict quality and safety standards while minimizing machine downtime. The ideal candidate possesses a mix of strong technical troubleshooting skills and high attention to detail within a regulated manufacturing environment.

Key Responsibilities

Manufacturing Team Leader

·        Participating in training prior to performing quality critical operations.

·        Overseeing the maintenance of manufacturing equipment to support the production schedule.

·        Preparing and shipping finished products.

·        Training Assemblers to perform their assigned job functions, in accordance with documented procedure and that the documentation for those personnel is current and complete.

·        Monitoring the quality of assembly work performed under their direction.

·        Inspecting raw materials, components, intermediates and finished products to assess quality in accordance with written procedures.

·        Immediately alerting the Management Representative of any condition that might compromise product quality.

·        Monitoring product and raw material inventory levels and requisitioning new materials as required.

·        Documenting inventory, manufacturing, assembly and packaging activities in accordance with written procedures and device history record requirements.

·        Maintain a sanitary, neat and orderly work area in accordance with cleaning procedures.

·        Maintaining current with changes and revision to the overall Quality System.

·        Maintaining current to changes and revisions to the procedures, documents and processes required to perform specific job functions.

Packaging & Production Operations:

·        Set up, calibrate, and operate automated packaging machinery and conveyor systems to assemble, fill, and seal single-use foil pouches.

·        Monitor equipment performance continuously, adjusting settings like heat-seal temperatures and mechanical alignment to match strict design specifications.

·        Perform careful visual and manual inspections of packaged goods to verify seal integrity, precise cutting, and correct labeling.

·        Maintain a steady, efficient workflow by refilling raw materials and packaging components on the production line.

Equipment Maintenance & Troubleshooting:

·        Perform routine and preventative maintenance (PM) inspections, including component lubrication, wear checks, and part replacement.

·        Diagnose, troubleshoot, and repair mechanical, pneumatic, and electrical issues on production and packaging machinery.

·        Dismantle, fix, and precisely reassemble machinery components using equipment manuals, technical diagrams, and schematics.

·        Maintain accurate physical and digital logs of packaging output, quality checks, parts inventory, and completed maintenance tasks.

·        Strictly adhere to all workplace safety compliance standards, including Lock-Out/Tag-Out (LOTO) protocols.

·        Maintain an organized physical and digital filing system to support our ISO 13485-certified quality management system and FDA compliance.