Questions you might be asking
What will I actually do?
You’ll report to the Department Manager and guide precision components through post-machining operations to meet medical device standards. You will prepare materials, choose the correct process routing, and ensure every part is finished, inspected, and documented properly.
- Run core processes: tumbling, blasting, heat treat, laser welding, laser marking, passivation, and anodize.
- Verify quality with microscope, micrometer, caliper, pin gauges, thread gauges, comparator, and Micro‑Hite.
- Complete and compile documentation to comply with ISO 13485 and Quality Inspection requirements.
- Maintain strict material identification, control, and full traceability for both conforming and nonconforming material.
- Promote Quality Best Practices and participate in GDP/GMP continuous improvement.
- Record all inspection and traceability activities in ERP and QMS systems.
- Follow occupational Safety and Health and PPE guidelines at all times.
- Comply with the TOMZ Quality Management System and take on other duties as assigned.
What experience do I need?
- Background in Class I/II/III medical device manufacturing or in regulated sectors such as Aerospace, Defense, or Pharmaceutical.
- Working knowledge of GMP/ISO standards and hands-on familiarity with mechanical metal finishing equipment.
- Comfort using basic hand tools for preventive maintenance.
- Ability to read blueprints, specifications, and procedures accurately.
- Strong attention to detail, on-time execution, and good organization.
- Self-directed and collaborative; able to work with R&D, Manufacturing, and QA with minimal guidance.
- Preferred: strong English communication skills (written and verbal).
What about education and years of experience?
- High school diploma, GED, or equivalent directly transferrable work experience (Manufacturing or Engineering preferred).
- 2–5 years in a regulated manufacturing environment.
What are the physical and environmental expectations?
- Ability to bend, stoop, squat, kneel, and lift up to 50 lbs; team lift or mechanical assistance required over 50 lbs.
- Exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials; PPE (safety glasses, dust masks, ear plugs, cut‑resistant or chemical‑resistant gloves) and engineering controls may be required.
- Comfort standing or sitting for extended periods.