Complaint Investigator
$49,920–$72,800 year
On-siteIrvine, California, United States
Job Summary
Conduct investigations on product complaints for company-manufactured items by interfacing with customer service, field teams, and customers to gather information and identify root causes. Document findings using good documentation practices, escalate potential recalls or safety issues to Quality Management, and drive corrective and preventive actions based on engineering analysis. Maintain complete complaint files and databases in compliance with FDA Regulations and ISO 13485, perform data trending, and prepare correspondence for internal and external stakeholders. Assist in audit preparations and participate in post-market surveillance projects as required.
Required Qualifications
- Bachelor's degree in science or related discipline
- 1+ years relevant or similar experience
- Must be able to demonstrate ability to understand the medical device product and its application
- Proficient computer skills and knowledge of relevant business applications, Microsoft Office applications
- Must be detail oriented
- Critical thinking and strong problem-solving skills
- Effective verbal and interpersonal skills
- Demonstrates good judgement in selecting methods and techniques for obtaining solutions
- Must be able to communicate verbally and in writing, and to receive and understand verbal and written instructions in English
- Able to work effectively both independently and in a collaborative team environment
- Must be able to lift up to 20 pounds
Desired Qualifications
- Preferred knowledge of FDA Medical Device Reporting and Quality System Regulation (21 CFR Part 803, 806, and 820), and ISO Standards (ISO 13485-QMS, ISO 14971-Risk Management), as they relate to complaint investigations or equivalent
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