Quality Complaints Management Specialist - Urgent Need
Company: millenniumsoft
Location: San Diego
Posted on: April 1, 2026
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Job Description:
Position : Quality Complaints Management Specialist Location :
San Diego, CA Duration : 12 Months Total Hours/week : 40.00 1st
Shift Client: Medical Device Company Job Category: Healthcare Level
Of Experience: Mid-Level Employment Type: Contract on W2 (Need US
Citizens or GC Holders Only) Work hours: 8:30 – 5 M-F Job
Description: The Specialist, Clinical Customer Advocacy 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.
Duties and Responsibilities: Collaborate with appropriate clinical,
technical, and/or regulatory employees to determine and track
product event status Assures timeliness and compliance with all FDA
regulations and standards related to the review of
events/complaints for BD products Write and submit complaint
investigation reports into the complaint management system.
Coordinate, research, and prepare correspondence in response to FDA
and global regulatory agencies requests for additional information
Maintain complaint in accordance with regulatory requirements.
Comply with the site Quality System. Performs other duties as
assigned. Performs other duties as assigned. Knowledge and Skills:
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.
Education and 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.
Keywords: millenniumsoft, Oceanside , Quality Complaints Management Specialist - Urgent Need, Science, Research & Development , San Diego, California
