California Licensed Principal Quality Engineer

A company is looking for a Principal Quality Engineer.

Key Responsibilities

Ensure product quality, safety, and effectiveness through quality assurance and control systems

Oversee product safety and reliability requirements, and collaborate with engineers on risk assessments and mitigations

Develop and maintain inspection and testing methods for finished products and incoming components

Required Qualifications

Bachelor's Degree in Electrical Engineering or equivalent

Minimum 3-10 years of experience in Quality Engineering within the medical device industry

Experience with software-controlled / electronic medical devices is preferred

Knowledge of QSR and ISO 13485 requirements in a Class III environment

Experience in risk analysis, failure analysis, and CAPA