About this role
Location: Wakeman, OH
Schedule: M-F; sometimes weekends.
Hours: Flexible start time
RESPONSIBILITIES:
The duties & responsibilities of the Manufacturing Associate include, but are not necessarily limited to the following:
• Perform bench-type processes to complete mechanical and electrical assemblies and sub-assemblies, using hand tools, and electronic and pneumatic tooling. Assemble Exsurco product and equipment as required.
• Perform in-process testing on product and/or components.
• Working in the Cleanroom, complete tasks for the cleaning and processing of Amalgatome blades as assigned by Supervisor.
• Adhere to policies and procedures assigned to work area.
• Assemble blades, handpieces and sub-assemblies for both the medical device and non-medical device product line following Work Instructions.
• Report defective materials or questionable conditions to the department supervisor and ensure documentation is completed in a timely manner.
• Maintain work area and equipment in a clean and orderly condition as per associated procedures.
• Follow prescribed safety regulations (i.e. Proper PPE).
• Complete Exsurco Quality System Training and ensure compliance to all manufacturing processes.
• Complete tasks as directed by manufacturing schedules with minimal supervision.
• Must be able to accurately count and track parts.
TRAINING REQUIREMENTS
• General Safety, including Hazard Communication, Lock-Out/Tag-Out Awareness, Emergency Preparedness/Evacuation.
• Electrostatic Discharge Awareness.
• Foreign Object Damage Awareness.
• Quality System Awareness.
• Maintain compliance to the Exsurco Quality Management System.
PHYSICAL DEMANDS
• Light physical effort equal to frequent lifting or moving of lightweight materials.
• Ability to lift 50 lbs.
• Regularly required to sit or stand, bend and reach.
• Employees may be subject to random drug and alcohol testing per Exsurco policy.
PERSONAL PROTECTIVE EQUIPMENT
• The use of Safety Glasses is required in designated areas.
• The use of Safety Toe Boots is required in designated areas.
• Other PPE required as needed per Exsurco SOPs.
WORK ENVIRONMENT
• Work performed in a climate-controlled shop environment or cleanroom.
• Work primarily performed inside class 7 cleanroom.
• Exposed to any number of elements but with none present to the extent of being disagreeable.
• May work at different workstations as production needs require, or shifts from one station to another, during the assembly process.
• Will be required to perform other duties as requested, directed or assigned.
• Must be able to adhere to cleanroom attire and hygiene requirements.
Skills/Qualifications:
• High School Diploma or GED required.
• Must have a good command of the English language. Must be able to read, understand and interpret written and verbal instructions.
• Following established methods and procedures, must be able to perform, but not limited to the following operations necessary to equipment - cut and strip wire, use wrenches and tools associated with assembly processes, be diligent in all aspects of quality,
• Use and be familiar with assembly and measuring tools, interpret visual aids/diagrams and must be able to perform simple shop math.
• Understanding of and Adherence to cGMP, GDP and ISO 13485 standards.