2.0 Disposable Production Line Lead

**Position Title**:2.0 Disposables Equipment Production Line Lead**Reports To**:Plant Manager**Department**:Operations**Summary of Position **(Paragraph form)**:The 2.0 Disposables Equipment Production Line Lead position is a hands-on leadership role, with responsibility to provide oversight and supervise assemblers in a team environment, and to assist Plant Manager & Manufacturing Engineer(s) so products meet all aspects of the Quality System and Regulatory guidelines.2.0 Disposables Equipment Production Line Lead is responsible to supervise production staff for the execution of established work instructions, equipment maintenance, cleaning and hygiene procedures for production of finished goods and products for sale.This position is responsible to oversee training of new employees as it relates to manufacturing and its related processes, as well as ensuring documentation is completed for training.2.0 Disposables Equipment Production Line Lead is also responsible for oversight and assistance with all aspects of safety of personnel in the manufacturing process.This position must ensure procedures are in place and followed to meet ISO ***** and FDA guidelines for compliance.**Primary Responsibilities **(Bulleted form)**:- Supervise production personnel in all aspects of the manufacturing process- Provide training and support to ensure all personnel are properly trained to perform their job, ensuring the training is well documented- Work with various departments; Regulatory, Sales & Marketing, Inventory & Logistics, Quality, to meet company goals and objectives for ISO ***** and FDA compliance.- Provide guidance to production personnel for efficient operations as it relates to manufacturing- Provide technical support to Regulatory affairs as it relates to Complaint Handling, CAPA, etc.- Ensure the safe work practices are adhered to by manufacturing personnel- Generate purchase requests for materials required in the service area.- Ensure enough raw material is at each work station to complete the day's production- Write and maintain team goals, objectives, and reviews- Maintain appropriate daily/weekly metrics- Ensure established procedures are in place and followed for all aspects of manufacturing- Work closely with Quality, Inventory & Logistics, to ensure efficient flow of materials and compliance to Quality System guidelines.- Cross-train to be fully qualified in all production & manufacturing activities- Understand company policies, Quality System, and its documentation requirements, to meet FDA compliance.- Compliance with all personnel policies- Must be able to alternate walking, standing & sitting during 8-hour day- Continuous execution of repetitive motion.- Frequent execution of lifting supplies and parts weighing up to 50lbs.- Must wear clean room clothing for 8-hour shift including, but not limited to jacket, safety glasses, and hair net.**Position Requirements - Education, Knowledge, Years of Experience, etc.**(Bulleted form)**:- 2.0 Disposables Equipment Production Line Lead should have a high school diploma or equivalent.- 2.0 Disposables Equipment Production Line Lead should have a minimum of 1-2 years prior supervisory experience in a manufacturing environment or equivalent.- Excellent mechanical and skills are required, along with an inherent understanding of mechanical devices, and the ability to troubleshoot a variety of systems.- Previous supervisory experience in an ISO environment is ideal with FDA related experience a plus.- Computer skills using Microsoft Office products are required.- An ability to use measuring devices, work with small components, and record detailed information is required.- Experience developing work instructions, procedures, and implementation of those instructions is ideal.- Must have experience with and demonstrable competencies in Lean Manufacturing (e.g. Toyota Production System).Including leading Kaizens/Continuous Improvement techniques, Standard Work, Single Piece Flow, Kan Ban, 5S, SMED, Value Stream Mapping, and Poka Yoke