At TOMZ, every part you produce contributes to devices used in healthcare. Reporting to the Operations Supervisor, you will manufacture precision components and document your work to ISO 13485 standards while operating advanced CNC equipment and performing detailed inspections.
You start by reviewing the production schedule and routers in our ERP system, confirming materials and traceability before touching a machine. You set up and run a 3-, 4-, or 5-axis mill, a mill-turn, or a Swiss lathe (Citizen or Tsugami), and you verify first-piece quality using a microscope, micrometers, calipers, pin and thread gauges, a comparator, and a Micro-Hite. Throughout the shift you monitor process stability, document to our Quality Management System, and team up with peers to resolve complex machining challenges. You finish your day with complete inspection records and clean, safe work areas.
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Operate and maintain production equipment including Robo Drills, mill-turns, horizontal and vertical mills, Citizen and Tsugami CNC Swiss lathes, and Index multi-spindle lathes.
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Perform visual and dimensional inspections using microscope, micrometer, caliper, pin gauges, thread gauges, comparator, and Micro-Hite.
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Troubleshoot and support problem-solving activities for complex machine or process issues.
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Complete and compile documentation aligned to quality inspection standards and ISO 13485.
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Ensure proper material control, identification, and traceability for conforming and nonconforming materials.
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Support Quality Best Practices and contribute to continuous improvement of GDP/GMP.
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Use ERP and QMS systems to record inspections and control traceability.
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Maintain safe working conditions and follow all occupational safety and PPE requirements.
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Adhere to the TOMZ Quality Management System and perform other duties as assigned.
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Basic understanding of mechanical equipment operation, care, and inspection processes.
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Ability to use hand tools for preventive maintenance, minor repairs, and tool changes.
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Ability to read and interpret blueprints, specifications, and procedures.
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Strong attention to detail with timely, accurate task completion.
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Foundational knowledge of GD&T.
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Familiarity with GMP/ISO standards.
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0-2 years in a regulated manufacturing environment.
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Background in Class I, II, and/or III medical device manufacturing.
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Experience in regulated industries such as aerospace, defense, or pharmaceutical.
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Strong verbal and written communication in English.
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Ability to bend, stoop, squat, kneel, and lift up to 50 pounds (team lift or mechanical assist required over 50 pounds).
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Perform repetitive hand and arm movements while handling up to 20 pounds, including gripping, twisting, placing components for extended periods, and lifting overhead.
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20/20 vision (assisted or unassisted) for sorting raw and non-conforming materials; good dexterity for small to medium products.
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Work around oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, and coolant; PPE such as safety glasses, dust masks, ear plugs, and cut-resistant or chemical-resistant gloves, along with engineering controls, may be required.
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Ability to sit or stand for prolonged periods.
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CNC Swiss lathes (Citizen, Tsugami), Robo Drills, Index multi-spindle lathes, horizontal/vertical mills, and precision metrology equipment including comparator and Micro-Hite.
