Job Description

Role Overview

As a key contributor on our production team, you will report to the Department Manager and guide parts through each step of the department’s workflow. TOMZ produces medical device components through precision machining, surface finishing, assembly, and anodizing. In this role, you’ll maintain ISO 13485 documentation, stage materials for processing, and complete visual and dimensional inspections on finished parts.

A Day in the Life

• Prepare and run components through metal finishing and related processes, including:
  • Tumbling
  • Blasting
  • Heat treat
  • Laser welding
  • Laser marking
  • Passivation
  • Anodize
• Carry out inspections using tools such as a microscope, micrometer, caliper, pin gauges, thread gauges, a comparator, and a Micro-Hite.
• Record and maintain all documentation required by ISO 13485 quality standards.
• Maintain identification, status, and full traceability for both conforming and nonconforming material throughout manufacturing.
• Support continuous improvement aligned with GDP/GMP and quality best practices.
• Use ERP and QMS systems to ensure inspection data and traceability are captured and controlled.
• Follow safety practices and PPE requirements; uphold the TOMZ Quality Management System.
• Perform other related duties as assigned.

Qualifications

• Experience in Class I, II, and/or III medical device manufacturing.
• Background in regulated industries (e.g., Aerospace, Defense, Pharmaceutical).
• Working knowledge of GMP and ISO standards.
• Hands-on experience with mechanical metal finishing equipment and processes.
• Ability to use basic hand tools to conduct preventive maintenance.
• Proficient at reading blueprints, specifications, and procedures.
• Exceptional attention to detail with reliable follow-through and timeliness.
• Self-starter who works well both independently and within a team.
• Comfort partnering with R&D, Manufacturing, and QA to deliver results with minimal guidance.
• Strong organizational skills.

Education & Experience

• High school diploma or GED; equivalent directly transferrable work experience accepted (Manufacturing or Engineering discipline preferred).
• 2–5 years of experience in a regulated manufacturing environment.

Preferred Skills

• Strong written and verbal communication in English.

Physical & Work Environment Requirements

• Able to bend, stoop, squat, kneel, and lift up to 50 lbs (team lift or mechanical assist required above 50 lbs).
• Work may involve exposure to oil, grease, noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp edges; PPE such as safety glasses, dust masks, ear plugs, and cut-resistant or chemical-resistant gloves, along with engineering controls, may be required.
• Capable of sitting or standing for extended periods.

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