Operator I

Job Title

Job Overview:

Requirement/Must Have:

• 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.

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.

Nice to Have:

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

Qualification And Education:

• High School Diploma or equivalent required.