Summary of Position :
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 Production Supervision & Manufacturing Engineer(s) so products meet all aspects of the Quality System and Regulatory guidelines. 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. 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 13485 and FDA guidelines for compliance.
Primary Responsibilities :
Position Requirements - Education, Knowledge, Years of Experience, etc.:
- 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 13485 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.
- Update work instructions as needed
- Ability to safely and successfully perform essential job functions consistent with the ADA, FMLA & other federal, state & local standards
- Ability to maintain reasonably regular, punctual attendance consistent with the ADA, FMLA & other federal, state and local standards
- 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 20lbs.
- Must wear clean room clothing for 8-hour shift including jacket, safety glasses, and hair net.
- Production Line Lead should have a high school diploma or equivalent.
- Production Line Lead should have prior supervisory experience in a manufacturing environment or equivalent.
- Excellent mechanical and/or electromechanical skills are required, along with an inherent understanding of electromechanical 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.