This role supports manufacturing operations in the areas of production, secondary operations, finishing, packaging, documentation, continuous improvement and other duties associated with production of medical devices. Work is in accordance with all requirements for manufacturing medical devices per FDA regulations. The operations lead will facilitate value stream communications and process flow, serve as a primary point of contact for issue resolution, assist leadership in various functions, support operations to achieve departmental goals and coordinate with business partners throughout the plant.
POSITION DUTIES & RESPONSIBILITIES:
· Follow appropriate safety practices to prevent accidents to self or others.
· Follow all laws and policies as they apply to one's job and to maintain the highest levels of professionalism, ethics and compliance at all times.
· Participate in and understand all compliance related activities pertaining to the job assignment.
· Assists with coordination of preventive maintenance and 5S related tasks as it pertains to the assigned area.
· Understand and execute lean initiatives (e.g. 5S, Standard Work). Suggest improvements to processes using lean principles.
· Engage with others in a positive and constructive manner that is conducive to good teamwork in a production environment.
· Proficiently perform process requirements and metrics in assigned area to meet safety, quality, compliance and production goals as well as training requirements.
· Work during assigned shift schedule and meet associated attendance requirements.
· Demonstrate consistency in results.
· Work with other departments, department leads, trainers and engineers to resolve quality issues.
· Identify and offer ideas and solutions for improvements based on applied knowledge.
· Develop and maintains reports as required. Reviews hourly, daily and weekly production rates against schedule.
· Support Manufacturing Continuous Improvement targets (CIPs).
· Support maintenance of training curricula and cross-training matrices.
· Assist and coordinate production efforts to cover demand of a assigned cell or area.
· Promote and encourage participation of cell members to identify opportunities for improvement.
· Assist in development of SOP's, other control processes and practices.
· Assists with quality non-conformance investigations and product dispositions.
· Performs other related duties, as required.