Job Description

Summary of Position:

Reporting to the Operations Supervisor, this position will have direct responsibility for the manufacturing of components through various basic functions within the Department. TOMZ manufactures parts via high precision metal machining, finishing, assembly, and anodizing processes for Medical Devices. The successful candidate will be expected to maintain the ISO 13485 standards documentation, operate equipment, and perform visual and dimensional inspections on machine components.

Essential Functions:

• Operate and maintain 3-4-5 axis production equipment, including Robo Drills, Mill Turn, and horizontal/vertical mills. Citizen Lathes, Tsugami Lathes, Index multi-spindle lathes.
• Perform visual and dimensional inspections on manufactured components, as required using a microscope, micrometer, caliper, pin gauges, thread gauges, comparator, Micro-Hite, etc.
• Support problem-solving activities for complex machine or process issues.
• Complete and compile documentation related to quality inspection standards.
• Ensure proper material control, identification, and traceability for conforming and nonconforming materials.
• Support Quality Best Practices and contribute to continuous improvement efforts of GDP/GMP.
• Utilize ERP and QMS systems to document and control inspection and traceability activities.
• Must maintain safe working conditions and follow occupational safety and health requirements including Personal Protective Equipment (PPE) guidance and rules.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Qualifications:

• Basic understanding of the usage and care of mechanical equipment and inspection processes.
• Ability to use hand-held tools for preventive maintenance, repairs, and tool changes.
• Ability to effectively read and understand blueprints, specifications, and procedures.
• Detail-oriented with the ability to maintain accuracy and complete tasks promptly.
• Basic understanding of GD&T.
• Knowledge of GMP/ISO standards.

Experience:

• Minimum of 0-2 years’ experience in a regulated manufacturing environment.

Preferred Skills:

• Class I, II and/or III Medical Device manufacturing experience.
• Regulated manufacturing industry experience (e.g., aerospace, defense, pharmaceutical, etc.).
• Strong verbal and written English language communication skills.

Physical Requirements:

• Ability to bend, stoop, squat, kneel, and lift up to 50 pounds. Team lift or mechanical assistance required for objects over 50 pounds.
• Perform repetitive hand and arm movements while lifting up to 20 pounds, including gripping, twisting, and placing components for extended periods, and lifting objects overhead.
• 20/20 vision (assisted or unassisted) required for sorting raw and non-conforming materials. Good dexterity is needed for managing small to medium products.
• Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. Personal protective equipment (PPE) such as safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves, and engineering controls may be required.
• Ability to sit or stand for prolonged periods.

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