Manufacturing Team Lead

As a Manufacturing Team Lead you will play a crucial role in the production of medical devices. You are to lead a manufacturing team to ensure the efficient and timely manufacturing of high-quality products that meet regulatory standards.  Manufacturing Team Lead will provide direct labor for the manufacturing of high-quality diagnostic products using manual and semi-automated equipment, which includes preparing/completing required documentation on manufacturing procedures. This position is responsible for maintaining the manufacturing schedule, interpretation of in-process data, and making important decisions for manufacturing processes. This position utilizes good judgment and critical thinking skills to make high level team / production decisions regarding the quality of the products manufactured. This position is responsible for the development and aiding of goal setting of junior manufacturing associates / direct reports, and schedule adherence. To perform this job successfully, an individual must be able to capably perform each of the following essential functions:  ResponsibilitiesPerform manufacturing tasks according to standard operating procedures (SOP) / process operating procedures (POP) and work instructions following current Good Manufacturing Practice (cGMP) and ISO 13485 quality systems.Subject matter expert for all applicable manufacturing equipment and machinery.Lead continuous improvement initiatives to enhance productivity and efficiency in manufacturing operations.Lead and train junior manufacturing associates in proper procedures, techniques, and safety protocols.Collaborate with cross-functional teams, including Project Management, Engineering, Quality Assurance, and Supply Chain, to aid / perform projects (NPD), validation activities, resolve issues, and implement process enhancements.Own / perform investigation and resolution of non-conformances, out of specifications, and deviations, implementing corrective and preventive actions as needed.Draft high level manufacturing instructions for manufacturing daily work as needed; review manufacturing instructions for correctness and completeness to ensure daily work is completed by manufacturing associates appropriately.Perform required batch record reviews for completeness and good documentation practices.Supervise, if applicable, the effective working of manufacturing personnel and prepare production schedules, taking into consideration equipment and/or resource constraints, and ensuring a commitment to both quality and company policies.Review and analyze chemistry and serological test data after each manufacturing stage; Consult with supervisor to determine what further processing, if any, is required based on test data.Maintain records of key performance indicators (KPIs) and provide regular progress reports to the manager.Balance quality, productivity, cost, safety, and morale to achieve positive results in all areas of manufacturing, striving for continuous improvement.Aid in direct reports competencies and goals.Support additional departments as assigned to cross train and aid the business unit.Additional functions, not specifically outlined in this position description as directed by the supervisor or manager.