Customer Complaints Specialist (Must Have Trackwise, Complaint Investigations, Trending)
Job Details
Full Job Description
Job Title - Customer Complaints Specialist (Must Have Trackwise, Complaint Investigations, Trending)
Location - San Diego, CA
Duration – 12+ Months Contract
Total Hours/week - 40.00
1st
Shift
Client: Medical Device Company
Job Category: Quality
Level Of Experience: Seniority Level
Employment Type: Contract on W2 (Need
US Citizens Or GC Holders Only)
Primarily Remote
position, but must be local to go onsite as needed – looking to
interview and fill quickly.
Description:
3 Must haves on the resume:
-Experience with
Trackwise
-Experience with Complaint Investigations
-Experience with Complaint Trending
The Specialist, Customer
Complaints is responsible for the completion of all tasks associated
with complaint management and processing of event reporting, including
communication for regulatory compliance with medical device reporting
for both domestic and international agency regulations.
Job
responsibilities, not limited to:
• Collaborate with
appropriate clinical, technical, and/or regulatory employees to
determine product event status and MDR reportability
• Assures
timeliness and compliance with all FDA regulations and standards
related to the review of events/complaints for BD products
•
Write and submit eMDR reports to the FDA and Health Canada in strict
adherence with regulatory requirements and timelines.
•
Coordinate, research, and prepare correspondence in response to FDA
and global regulatory agencies requests for additional
information
• Maintain complaint and MDR file documentation in
accordance with regulatory requirements. Completes global complaint
handling and adverse event reporting activities related to BD
products
• Comply with the site Quality System.
• Performs
other duties as assigned.
Qualifications
Education & Experience
• Bachelor’s degree
(chemistry, engineering, nursing) strongly preferred.
• 1 to 2
years’ experience in Quality, Regulatory or Complaint management is
preferred. May consider equivalent combination of education and
experience.
Knowledge, Skills & Abilities
•
Working knowledge of QA, Regulatory/Quality Compliance in a medical
device industry.
• Attention to detail is essential.
• Able
to utilize computers for development of reports and summary of project
experience.
• Strong proficiency with MS Office tools to include
Word, Excel, PowerPoint and Outlook.
• Prior work experience with
TrackWise Complaint Handling System preferred.
• Prior experience
filing eMDRs preferred.
• Ability to work on multiple projects
with various disciplines are essential.
• Ability to multitask in
an ever-changing environment.
• Position requires
innovative/critical thinking, ability to solve problems and meet
deadlines.
• Strong communication, organization, presentation,
and writing skills.