Job Title: Quality Engineer

Location: Irvine, CA (Onsite)

Overview:

Seeking a Quality Engineer to support quality assurance and compliance activities within a regulated medical device manufacturing environment. The role involves ensuring product quality, supporting quality systems, and driving continuous improvement while maintaining compliance with FDA and ISO regulatory standards.

Required Experience:

• 3+ years of experience in medical device or regulated manufacturing environments

• Strong knowledge of FDA 21 CFR Part 820 and ISO 13485

• Hands-on experience with CAPA, Deviation, and Non-Conformance (NCR) management

• Experience conducting Root Cause Analysis (RCA) using tools such as 5-Why or Fishbone

• Experience with risk management and quality documentation

• Knowledge of GMP and quality management systems (QMS)

Key Responsibilities:

• Support and maintain Quality Management System (QMS) in compliance with regulatory requirements.

• Investigate and manage deviations, non-conformances, and CAPA activities.

• Perform root cause analysis and implement corrective and preventive actions.

• Review and approve quality documentation including procedures, reports, and records.

• Collaborate with manufacturing, engineering, and regulatory teams to ensure product quality and compliance.

• Support internal audits, supplier quality activities, and regulatory inspections.

• Monitor quality metrics and drive continuous improvement initiatives.