Sr Quality Engineer

Location : Irvine, CA

Schedule : Standard Office Hours

Duration : 12-Month Contract

Pay Range : $53.00 - $58.00 / hour

Job Description

Summary :

The Senior Quality Engineer will focus on implementing and optimizing quality engineering practices related to complaints investigation, post-market surveillance, and risk management. This role ensures compliance with global regulatory requirements while fostering a culture of quality across all product lines.

Job Responsibilities

In this role, you will manage and support a variety of projects within the Quality Engineering department. Key responsibilities include :

• Investigate complex manufacturing quality and compliance issues (e.g., CAPA, non-conformances, audit observations) based on engineering principles.
• Execute complaint investigations using a multifunctional, systematic approach to resolve issues effectively and in compliance with procedures.
• Lead post-market surveillance activities for approved products, ensuring all complaints are properly tracked and completed on time.
• Develop, update, and maintain technical content for risk management files.
• Collaborate with investigation owners and cross-functional teams to address overdue cases and enhance investigation quality.
• Analyze data, make recommendations, and generate detailed reports based on investigation findings.
• Identify and implement opportunities for process improvements and efficiency within quality systems.

Knowledge & Skills

Education & Experience