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Job Summary
The Operator is responsible for assembling mechanical, electrical, and electronic components while performing testing, calibration, and inspection to ensure all products meet quality and regulatory standards. This role requires precision, efficiency, and adherence to safety and compliance procedures. The Operator works collaboratively with engineering, quality, and production teams to achieve daily build goals and support continuous improvement initiatives. Job Responsibilities
Assemble instruments and components using hand and power tools, fixtures, and limited automated equipment.
Perform product testing, calibration, and verification to ensure accuracy, reliability, and compliance with specifications.
Inspect components and finished products to ensure adherence to FDA, ISO, and internal quality standards.
Troubleshoot assembly or production issues in collaboration with engineering, quality, and product development teams.
Document production activities, including material usage, equipment checks, and non-conformance reports.
Follow all Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), and Quality Management System (QMS) requirements.
Maintain a safe, clean, and organized work environment.
May train and assist other assemblers as needed based on demonstrated skill and proficiency.
Perform additional duties as assigned.
Job Requirements
Ability to read and interpret technical drawings, assembly instructions, and specifications.
Skilled in the use of hand and power tools such as screwdrivers, wrenches, and measuring devices.
Strong verbal and written communication skills.
Basic computer literacy and ability to accurately document production activities.
Solid mathematical comprehension and mechanical aptitude.
Good hand-eye coordination and manual dexterity.
Ability to lift and move up to 50 pounds.
Education
Work Experience
Prior experience in regulated manufacturing environments (e.g., FDA, ISO) preferred.
Familiarity with GMP and quality system requirements desirable.
Previous experience in mechanical or electronic assembly a plus.
Additional Job Details
Location: Irving, TX
Schedule: 6:00 a.m. - 2:30 p.m.
Must adhere to all safety, quality, and compliance standards while maintaining productivity and accuracy.
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