Quality Assurance Compliance Specialist

Role: Senior Complaint Specialist – Investigation Lab

Location: San Diego, CA

Duration: 3 Months

Client: Medical

Role Summary:

The Senior Complaint Specialist supports post-market surveillance for medical devices by investigating product complaints. This role focuses on analyzing failed products, identifying root causes, documenting findings, and ensuring complaints are handled accurately and in compliance with regulatory and quality requirements. The position also provides technical support and troubleshooting when needed.

Key Responsibilities

• Investigate medical device product complaints and analyze failed products
• Work safely with products and materials in a controlled lab environment
• Write clear, accurate failure investigation reports
• Review complaint data to identify trends and support root cause analysis
• Ensure complaint files are complete, accurate, and meet documentation standards
• Make independent decisions related to complaint investigations, escalating issues when needed
• Collaborate with supervisors and cross-functional teams to assess complaint severity and resolve issues
• Handle and dispose of products per quality system requirements
• Ensure timely follow-up with internal teams and stakeholders
• Comply with FDA regulations, quality systems, and company procedures

Qualifications

• Bachelor’s degree in a related field preferred
• 3–5 years of experience in the medical device industry
• 2 years of experience in complaint handling, post-market surveillance, or regulated environments
• Knowledge of medical device regulations, quality systems, and compliance practices
• Electronics knowledge is a plus.

kindly share resume at gaurav@stellarconsulting.com or call me at 678-935-7045 to discuss more!