Manufacturing Assembly Associate

Exsurco Medical; Cleveland (OH); On-site; USD 30,000 - 40,000; Full time

Job summary

A medical device manufacturer in Cleveland, Ohio is seeking a Manufacturing Associate to perform mechanical and electrical assemblies and maintain compliance with quality standards. This role requires a High School Diploma or GED and proficiency in assembly and measuring tools. Candidates should be able to work in a cleanroom environment and adhere to safety regulations. This position offers an opportunity for individuals interested in the medical device sector with a focus on quality and attention to detail.

Qualifications

• Must have a good command of the English language, able to read, understand, and interpret instructions.
• Capable of following established methods and procedures in assembly tasks.
• Understanding of cleanliness requirements in a cleanroom environment.

Responsibilities

• Perform mechanical and electrical assemblies using hand and pneumatic tools.
• Conduct in-process testing and maintain records of defects.
• Follow safety regulations and maintain cleanliness in the work area.

Skills

Mechanical assembly

Electrical assembly

Quality control

Understanding of cGMP/GDP/ISO 13485

Basic math skills

Education

High School Diploma or GED

Tools

Hand tools

Electronic tooling

Pneumatic tooling

Job description

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

• 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.