Summary of Position with General Responsibilities:
The Manufacturing Supervisor provides direct supervision to the production personnel and assures the effective use of all the manufacturing resources to meet goals and requirements set forth by the Company and by Regulatory entities. Such requirements include, but are not limited to: Safety, Quality, GMP, ISO 9000, and Housekeeping standards.
Essential Job Functions:
•Supervises all personnel and operations monitoring production to assure control, adherence to safety, quality, and schedule requirements
•Assures adequate employee training and compliance to Regulatory and Company requirements and polices
•Maintains direct contact with support departments to resolve issues on a day to day basis
•Keeps records and issues reports as required to document the performance of the area supervised and to keep management informed of overall performance
•Participates actively in various Company programs (Lean Thinking, CIP’s, etc) geared to optimize performance, reduce costs and meet regulatory requirements
•Evaluates EE’s performance, administers the disciplinary procedure where applicable
•Assures for the training and certification of employees in all manufacturing procedures in which employees will participate
•Ensures monthly schedule goals are met and well planned (this is your responsibility, you are the owner an the one accountable to make it happen)
•Updates and corrects procedures for the operation of new or existing equipment
•Supports the incorporation of new technology for Company applications where feasible and practical
•Supports and coordinates the implementation of Lean Manufacturing strategies
•Identifies new opportunities for Process Improvement and assists in implementation
•Assists identifying and elimination of Non Value Added Activities
•Reviews Manufacturing lines start up, operation, labeling, package, release, and shipping logistic for appropriate process flow and documentation
•Assists in development and implementation of process improvements and optimization
•Updates, in coordination with the ME, Mfg. procedures, specifications, bill of materials, drawing, operating procedures and any other documentation needed to manufacture, test or purchase products
•Provides, in coordination with the Facilities Supervisor, all facilities and resources during the first production steps to assure on time start-up of new production items. Investigates availability of adequate machines accessories, tooling supplies, safety feature, inspections gauges and training
•Assists in establishing annual tooling and capital investment budget
•Analyzes value of product and methods with emphasis on cost reduction of labor, material, and auxiliary expenditures
•Motivates, manages and develops personnel in a team environment
•Performs monthly audits of area supervised for the compliance to Company goals and Regulatory requirements including but not limited to cGMP's, FDA, ISO 9002 and OSHA. (Written reports must be provided to immediate supervisor, and audit procedure must be followed)
Assures is trained before performing any task
Uses the required clothes, personal and security protective equipment according to the requirements of its operation
Complies with the cGMP's, Quality Standards and established policies and/or procedures
Executes other duties assigned by Supervisor.
Basic Qualifications:
•Must be bilingual (English/Spanish) and must have good communications skills both oral and written
•Basic knowledge of mathematics and statistics
•Must have knowledge of cGMP's, OSHA, and ISO 9000 requirements
• Teamwork oriented
Education and/or Experience:
•Bachelors Degree preferably in Engineering.
•3-5 years experience within a manufacturing environment, preferable in the Medical Device Industry.
Physical Demands:
As per Training Matrix.
PHYSICAL REQUIREMENTS AND WORK ENVIRONMENT
1. Frequency and percentage of a day the worker is required to do the following specific types of activities:
