Medical Device Quality Engineering Associate — Metrology & Validation

Role Overview

As a Medical Device Quality Engineering Associate reporting to the Quality Manager, you’ll help safeguard product quality in a regulated manufacturing environment. Your work balances hands-on metrology, data-driven risk reduction, and validation rigor to ensure every component meets stringent requirements.

A Day in the Life

You start your day on the shop floor, programming and operating advanced measurement systems—Vision Systems and CMMs—to verify critical features. You author inspection plans, define robust in-process controls, and guide teams on visual standards and standardized acceptance criteria for TOMZ’s manufacturing processes. Throughout the day, you collaborate with engineering peers to shape and refine test methods and execute Test Method Validations (TMVs), turning findings into practical improvements.

Midday, you contribute to risk management documentation with cross-functional teams, ensuring hazards are addressed and mitigations are traceable. You help develop Process Master Validation Plans and perform process qualifications, analyzing results and initiating corrections or corrective actions when needed. You champion First Article Inspections, provide hands-on direction for Incoming, In-Process, and Final inspections, and support the full lifecycle of gage calibration—from review to execution and evaluation.

Before you wrap, you track and report inspection metrics such as rejection rates, defect modes, and process trends across customers and product families. You create ECOs to release quality engineering documentation, reinforce Quality Best Practices and GDP / GMP continuous improvement, and ensure alignment with the TOMZ Quality Management System—plus other duties as assigned.

What You’ll Work With

• Advanced measurement tools : Vision Systems, CMMs, and precision instruments (calipers, micrometers, depth gages, indicators, and plug / thread Go / No-Go gages).
• Risk management files, inspection plans, visual standards, and acceptance criteria.
• CAPA methodologies and data analysis for process qualification and improvement.

Qualifications

Education

Experience

Preferred Skills

Travel

Physical Demands