Manufacturing Associate

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.