Junior Quality Engineer, Process Risk & Test Methods

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 internship preferred. 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.

Created: 2025-10-31