Quality Complaints Management Specialist - Urgent Need
Quality Complaints Management Specialist - Urgent Need
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
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: MidLevel
Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)
Work hours: 8:30 5 MF
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 everchanging environment.
- Position requires innovative/critical thinking ability to solve problems and meet deadlines.
- Strong communication organization presentation and writing skills.
Education and Experience:
- Bachelors 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.
Required Experience:
Unclear Seniority
Employment Type
Full Time
