Big Lake, MN
Posted 4 days ago
Summary of Position
Your day starts on the production floor at TOMZ, where precision matters. Reporting to the Department Manager, you guide complex medical device components through post-processing—from surface treatments to final markings—while upholding ISO 13485 documentation and uncompromising quality.
Essential Functions
- Prepare parts and run them through metal finishing operations, including tumbling, blasting, heat treat, laser welding, laser marking, passivation, and anodize.
- Conduct visual and dimensional inspections using tools such as a microscope, micrometer, caliper, pin gauges, thread gauges, comparator, and Micro-Hite.
- Complete, compile, and maintain documentation aligned with Quality Inspection standards and ISO 13485 requirements.
- Maintain strict material control, identification, and traceability for both conforming and nonconforming parts throughout manufacturing.
- Support GDP/GMP and Quality Best Practices with a mindset of continuous improvement.
- Use ERP and QMS systems to document inspections and preserve traceability and process control.
- Follow all occupational safety and health practices, including PPE requirements; uphold the TOMZ Quality Management System.
- Perform other duties as assigned.
Qualifications:
Education
- High school diploma, GED, or equivalent directly transferable work experience (Manufacturing or Engineering discipline preferred).
- 2–5 years of experience in a regulated manufacturing environment.
- Strong verbal and written English communication skills are preferred.
Preferred Skills/Qualifications
- Background in Class I, II, and/or III medical device manufacturing; or experience from a regulated field such as Aerospace, Defense, or Pharmaceutical.
- Working knowledge of GMP/ISO standards and regulated manufacturing practices.
- Hands-on experience with mechanical metal finishing equipment and processes, plus the ability to perform basic preventive maintenance with hand tools.
- Ability to read and interpret blueprints, specifications, and procedures accurately.
- Exceptional attention to detail, organization, and the ability to deliver work on time.
- A self-starter who can work independently and collaboratively across R&D, Manufacturing, and QA with minimal supervision.
Physical Demands
- Ability to bend, stoop, squat, kneel, and lift up to 50 lbs. Team lift or mechanical assist required above 50 lbs.
- Comfort working around oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials; 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.
$18 – $22 an hour