Operator I

Title: Medical Device assembler
Location: Irving, TX
Hours: 6:00AM to 2:30PM
Pay:17/hr

Summary

This role is responsible for assembling mechanical, electrical, and electronic components, performing testing and calibration, and ensuring compliance with quality and regulatory standards. Candidate will work efficiently to meet daily build goals and contribute to a culture of quality and continuous improvement.

Key Responsibilities:

• Assemble instruments and components using hand/power tools, fixtures, and limited automated equipment.
• Perform testing, calibration, and verification to ensure product accuracy and reliability.
• Inspect components and finished products for compliance with FDA and ISO standards.
• Troubleshoot production issues and collaborate with engineering, quality, and product development teams.
• Document production activities, including material control and non-conformance reports.
• Adhere to SOPs, cGMPs, QMS, and safety regulations.
• May train other assemblers based on demonstrated proficiency.
• Perform other duties as assigned.

Required Qualifications

• Ability to interpret technical drawings, instructions, and specifications.
• Skilled in using hand and power tools (e.g., screwdrivers, wrenches, measuring equipment).
• Strong verbal and written communication skills.
• Basic computer literacy and mathematical comprehension.
• Good hand-eye coordination and mechanical aptitude.
• Ability to lift 50 lbs or more.
• All candidates should demonstrate fluency in English, including strong reading, writing, and verbal communication skills, as these are essential for successfully completing training requirements.

Preferred Experience

• Prior experience in regulated manufacturing environments (e.g., FDA, ISO).
• Familiarity with GMP and quality systems.

Education: High School Diploma or equivalent required