Quality Engineer - Medical Devices (ISO 13485/QMSR 820)

Valid8 Financial, Inc.; Oak Creek (WI); On-site; USD 70,000 - 95,000; Full time

Job summary

Valid8 Financial, Inc. in Oak Creek, WI, seeks a Quality Engineer to ensure compliance with FDA QMSR 820 and ISO 13485 by performing inspections, tests and data analysis to support manufacturing operations and quality functions.

This role bridges hands‑on technical execution and engineering‑level solutions, upholding product quality, process control, and audit readiness across the organization.

Qualifications

• Associate or Bachelor’s degree in Engineering, Quality, or related technical field.
• Experience in a regulated manufacturing environment—medical device preferred.
• Strong understanding of cGMP, ISO 13485, and QMSR 820.
• Proficiency with measurement tools and inspection equipment.
• Strong documentation, communication, and analytical skills.

Responsibilities

• Performs incoming, in‑process, and final inspections using metrology tools.
• Manages daily product quality on the production line and addresses issues to meet customer requirements.
• Handles customer feedback and complaints, analyzes trends, and escalates to HQ Post‑Market as needed.
• Provides technical support for physical products and problem solving.
• Tracks post‑market data, initiates improvements, and supports FCA with HQ team.
• Develops inspection and control documents and trains employees.

Skills

Documentation

Analytical skills

Communication

Quality systems

Problem solving

Education

Associate or Bachelor’s degree in Engineering/Quality

Tools

Measurement tools

Job description

Valid8 Financial, Inc. in Oak Creek, WI, seeks a Quality Engineer to ensure compliance with FDA QMSR 820 and ISO 13485 by performing inspections, tests and data analysis to support manufacturing operations and quality functions.

This role bridges hands‑on technical execution and engineering‑level solutions, upholding product quality, process control, and audit readiness across the organization.