Production Lead Department Production Location Harrisburg, NC, United States Description Summary: Reporting to the Warehouse Supervisor, the Production Lead will be responsible for production of sterile and non-sterile medical supplies and devices. Majority of work responsibilities take place while gowned in a controlled environment and performed according to GMP and ISO guidelines. Essential Duties and Responsibilities include the following (other duties may be assigned): Completes training to stay current with job and procedural requirements; ensures production personnel training requirements are completed and kept current. Ensures all work related activities are documented by production personnel on the appropriate Production and Quality documents; provides oversight and completes/documents management review of production documents, as required. Sets up and/or operates various processing equipment i.e. vacuum sealer, kitting line, labeling, packaging, label printer as needed to meet production schedule. Accomplishes manufacturing staff objectives by communicating job expectations; planning, monitoring, and appraising job results; coaching, counseling, and disciplining employees; initiating, coordinating, and enforcing systems, policies, and procedures. Maintains staff by orienting, and training employees. Maintains work flow by monitoring steps of the process; monitoring personnel and resources; implementing cost reductions; developing reporting procedures and systems; initiating and fostering a spirit of cooperation within and between departments. Together with Warehouse Supervisor, completes production plan by scheduling and assigning personnel; accomplishing work results; establishing priorities; monitoring progress; revising schedules; resolving problems; reporting results of the processing flow on shift production summaries. Performs root cause analysis and completes investigation write-ups for production related non-conformances (NC); completes NC reports. Maintains quality service by establishing and enforcing organization standards. Ensures operation of equipment by scheduling or completing required preventative maintenance (PM); calling for repairs; documenting all PM and repair activities; evaluating new equipment and techniques. Provides manufacturing information by compiling, initiating, sorting, and analyzing production performance records and data; answering questions and responding to requests. Reviews systems and procedures by analyzing operating practices, record-keeping systems, forms and recommends improvements as needed. Maintains safe and clean work environment by educating and directing personnel on the use of equipment and resources; maintaining compliance with established policies and procedures. Resolves personnel problems by analyzing data; investigating issues; identifying solutions; recommending action. Contributes to team effort by providing resources and support to production personnel in the completion of company objectives. Requirements Education, Experience, Knowledge, Skills and Abilities: College Degree preferred Follows instructions and procedures, accurately documents completion of tasks Excellent manual dexterity Standing gowned for the majority of work day Attention to detail, strong analytical and organizational skills Strong leadership, interpersonal, written and verbal communication skills Must be able to assemble various products to be sold Experience working in ISO/GMP regulated production environment preferred Must have a minimum two (2) years of experience working in medical device manufacturing or related field in a team environment Computer skills including WORD, EXCEL, VISIO, GP, Salespad Strong work ethic and understanding of basic Quality systems Able to read and interpret documents such as safety rules, standard operating procedures, work process aids, company policies, and instruction manuals Able to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals Able to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form Able to compute rate, ratio, and percent Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vehicles. The noise level in the work environment is usually quiet to moderate. Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the responsibilities of the supervisor’s job, the employee is required to talk and hear. The employee is often required to sit and use his or her hands and fingers, to handle or feel. The employee is occasionally required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision. Training Requirements: The employee must be trained on all of the documents, procedures, software applications and topics outlined by Quality Assurance. Documentation of this training will be maintained with Human Resources. Additional training requirements may be added as deemed necessary by the supervisor.