Process Operator I

About the role

Reporting to the Department Manager, this position has direct responsibility for processing parts through various functions within the Department. TOMZ manufactures parts via high-precision metal machining, finishing, assembly, and anodize processes for Medical Devices. The successful candidate will maintain ISO 13485 standards documentation, prepare materials for processing, and perform basic visual and dimensional inspections on completed components.

Responsibilities

• Prepare and process components through various metal finishing operations:
  • Tumbling
  • Blasting
  • Heat Treat
  • Laser Welding
  • Laser Marking
  • Passivation
  • Anodize
• Perform visual and basic dimensional inspections on completed components using micrometers, calipers, microscopes, etc.
• Complete and compile necessary documentation related to Quality Inspection standards.
• Ensure proper material control, identification, and traceability for conforming and nonconforming material through manufacturing processes.
• Support Quality Best Practices and GDP/GMP continuous improvement efforts.
• Utilize and navigate ERP and QMS systems to document inspection and traceability activities.
• Follow occupational Safety and Health requirements, including Personal Protective Equipment (PPE) guidance.
• Adhere to the TOMZ Quality Management System.
• Perform other duties as assigned.

Requirements

• High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering discipline preferred).
• Minimum of 6 months–2 years’ experience in a regulated manufacturing environment.
• Ability to use basic hand-held tools for preventive maintenance activities.
• Strong background in the usage and care of mechanical metal finishing equipment and processes.
• Good organizational skills and attention to detail.
• Ability to effectively read and understand blueprints, specifications, and procedures.
• Strong verbal and written English language communication skills.

Preferred Skills

• Knowledge of and experience with GMP/ISO standards.
• Regulated manufacturing industry experience (e.g., Aerospace, Defense, Pharmaceutical).
• Class I, II, and/or III Medical Device manufacturing experience.

Physical Requirements

• Ability to bend, stoop, squat, kneel, and lift up to 25 pounds. Team lift or mechanical assistance required for objects over 25 pounds.
• 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.