Complaint Investigator Resume

Samantha Gray

North Highlands CA 95660

(916) 987-6543

[email protected]

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Job Objective

Accomplished Complaint Investigator searching for opportunity to put my skills and past experience to work to help company reach both short and long-term goals.

Highlights of Qualifications:

  • Vast experience in complaint handling, reporting and trending
  • Wide knowledge of FDA regulations, safety standards and regulatory compliance guidelines
  • Familiarity with FDA 21 CFR 820.198, QSRs, ISO 9001 and other medical device regulations
  • Proficient with Eclipse, Aria and 4DTC software
  • Exceptional ability to handle multiple tasks and conduct with accuracy and a high attention to detail
  • Ability to train and mentor local staff on quality, regulatory regulations and compliance issues
  • Strong ability to plan, schedule and prioritize own work routine to meet established schedule and support the activities of Q&R
  • Excellent written, oral communication and interpersonal skills
  • Proficient with computer and Microsoft Office

Professional Experience:

Complaint Investigator, August 2005 – Present

Philips, Wilmington, NC

  • Assigned investigative tasks to analyze root cause and resolution of identified complaints.
  • Collaborated with the Engineering, QE and support departments (SCS/SDL) to complete complaint analysis and compile investigation results.
  • Generated Medical Device Reports (MDRs) and Vigilance Reports.
  • Analyzed complaint data monthly to identify new and systemic issues as necessary.
  • Prepared responses to customers and field as necessary per process.
  • Provided training and guidance on reporting regulations.

Complaint Investigator, May 2000 – July 2005

Medical Systems, Inc., Wilmington, NC

  • Coordinated complaint data collection with customers, Application Specialists and local service personnel at technical investigation sites, as necessary.
  • Collaborated closely with Help Desk to re-create customer problems as necessary during complaint investigations.
  • Evaluated complaints to analyze whether an investigation is necessary and when appropriate, lead and participated in those complaint investigations.
  • Followed up with customers to evaluate adverse events and acquired other pertinent clinical information, as needed.
  • Performed peer reviews of complaint investigation documentation.


Bachelor’s Degree in Business Administration, Oberlin College, Oberlin, OH