Junior Quality Engineer, Process Risk & Test Methods

Job DescriptionJob Description Make an Impact from Day One

Join a regulated medical device manufacturing team where quality is built into every step. Reporting to the Quality Manager, you’ll combine metrology expertise, process risk reduction, and validation know-how to keep products compliant and reliable.

What You’ll Do

• Program and operate advanced measurement systems (Vision Systems and CMMs) and apply precision tools such as calipers, micrometers, depth gages, indicators, and plug/thread Go/No-Go gages.
• Create inspection plans and define in-process controls; help develop production visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes.
• Partner with engineering to define test methods and execute/evaluate Test Method Validations (TMVs).
• Support risk management documentation with cross-functional teams and help shape Process Master Validation Plans.
• Perform process qualifications, analyze data, and initiate corrections or corrective actions through the CAPA process.
• Provide hands-on direction for Incoming, In-Process, and Final inspection activities.
• Champion First Article Inspections (FAIs) to establish robust baselines.
• Assist with gage calibration review, management, execution, and evaluation.
• Reinforce Quality Best Practices and GDP/GMP continuous improvement.
• Track and report inspection data (rejection rates, defect modes, process trends) across customers and product families.
• Generate ECOs to release quality engineering documentation and comply with the TOMZ Quality Management System.
• Perform other duties as assigned.

What You Bring

• Proactive, self-directed mindset suited for a fast-paced environment.
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint).
• Strong English written and verbal communication skills.
• Basic knowledge of statistics and sampling strategies.

Education & Experience

• Bachelor’s or higher in Engineering, Manufacturing, or Business—or equivalent, directly transferable industry experience.
• 0–2 years in a regulated manufacturing environment; relevant .

Bonus Points

• ASQ-CQT, CQE, or CRE.
• GD&T certification.
• DMIS programming certifications.
• Experience with Class I/II/III medical devices or other regulated sectors (Aerospace, Defense, Pharmaceutical).

Travel

• Up to 15% travel, including possible multiple overnights and occasional weekends.

Physical Requirements

• Ability to bend, stoop, squat, kneel, and lift to 30 lbs; use team lift or mechanical aids above that threshold.
• Extended sitting and frequent computer use.
• Potential exposure to oil, grease, noise, cleaning solvents, dust, metal particles, sparks, coolant, and sharp edges; PPE and engineering controls may be required.