MAIN PURPOSE OF ROLE

Summarize the main purpose of the role.

Under general supervision, supports assigned area Production Supervisor in ensuring the continuous flow of high quality production through assigned work-cells in accordance with manufacturing obligations. Acts as the lead person in self-directed cells or teams. Assists in ensuring that high levels of productivity and product quality are consistently maintained, and helps coordinate efforts towards their continuous improvement.

MAIN RESPONSIBILITIES

•Responsible for coordinating production activity in assigned work areas, ensuring that product is continuously processed in accordance with build schedules.

•Coordinates communication of work instructions to personnel in designated areas in accordance with supervisory objectives.

•May perform direct manufacturing operations in support of build schedules, as directed or as necessary.

•Performs regular process and quality performance audits of personnel, tooling and equipment in assigned areas.

•Advises supervisor or other appropriate contact in the event of issues affecting the productivity of the cell.

•Accumulates information for assigned areas regarding work in process inventory status and daily output quantities.

•Assists in providing direct training to area operators as required. Provides feedback on defects encountered, and provides re-training support as necessary.

•Accumulates and organizes data to support area continuous improvement plans, as directed.

•Provides assistance in expediting priority product and tasks in assigned areas.

•Performs inspection and determines disposition of rejects per required documentation, as directed.

•Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.

•Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

•Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

•Performs other related duties and responsibilities, on occasion, as assigned.

•Works with a variety of production equipment, small hand tools, test equipment, and precision measuring instruments. Also uses standard office equipment such as telephone, fax/copier, and a personal computer with standard office software.

•Works in a production or air-conditioned clean-room manufacturing environment; requires gowning attire to maintain a particle free environment. Low to moderate noise level. Minor exposure to chemicals. May work at a desk or workstation.

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Requires a significant amount of sitting, stooping and walking; manual dexterity; ability to reach, hold, grasp, and move items. Subject to standing for extended periods of time. Must be able to perform occasional tasks requiring the physical lifting of equipment weighing up to approximately thirty pounds. Must be able to perform functions utilizing automated/manual equipment requiring correctable vision including color discrimination.