What are the responsibilities and job description for the Manufacturing Associate position at Exsurco Medical?
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.