Entry-Level Quality Systems and Metrology Engineer

Are You Ready to Turn Curiosity into Quality?

Do you enjoy solving complex problems with precise measurements and clear data? Are you excited to learn how process risk, validation, and CAPA come together to build safe, compliant medical devices? Reporting to the Quality Manager, this role lets you apply hands-on metrology and analytical thinking to real products in a regulated environment.

• Operate and program Vision Systems and CMMs; confidently use calipers, micrometers, depth gages, indicators, and plug/thread Go/No-Go gages to verify features.
• Write inspection plans, define process controls, and help create production visual standards and standardized acceptance criteria supporting TOMZ’s manufacturing processes.
• Collaborate to define test methods, then execute and evaluate Test Method Validations to ensure repeatable, reliable measurements.
• Contribute to risk management documentation with cross-functional teams and assist in building Process Master Validation Plans.
• Run process qualifications, analyze outputs, and initiate corrections or corrective actions via CAPA when gaps arise.
• Guide Incoming, In-Process, and Final inspection activities and champion FAIs to confirm manufacturability.
• Support the review, management, execution, and evaluation of gage calibration activities.
• Advance Quality Best Practices and GDP/GMP continuous improvement initiatives.
• Track/report inspection data—rejection rates, defect modes, and process trends—across customers and product families.
• Generate ECOs to release quality engineering documentation and follow the TOMZ Quality Management System.
• Take on additional responsibilities as assigned.

• Initiative to excel in a fast-moving environment.
• Comfort with Microsoft Office (Outlook, Word, Excel, PowerPoint).
• Strong English communication skills—both written and verbal.
• Basic familiarity with statistical methods and sampling strategies.

• Bachelor’s degree (or higher) in Engineering, Manufacturing, or Business—or directly relevant industry experience in lieu of a degree.
• 0–2 years in regulated manufacturing; internship experience is a plus.

• ASQ-CQT, CQE, or CRE.
• Certification in GD&T.
• DMIS programming certifications.
• Experience with Class I, II, and/or III medical devices; or exposure to regulated industries like Aerospace, Defense, or Pharmaceutical.

• Travel:
  Up to 15% annually; may involve multiple overnights and occasional weekends.
• Physical Demands:
  Bend, stoop, squat, kneel, and lift to 30 lbs (team lift or mechanical assist above 30 lbs); extended sitting; frequent computer use; exposure to oil, grease, occupational noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp-edged materials. PPE (e.g., safety glasses, dust masks, ear plugs, cut-resistant or chemical-resistant gloves) and engineering controls may be required.

TOMZ Manufacturing Corp