4348 Clarence Court
Wilmington, NC 28412
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
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