What are the responsibilities and job description for the Quality Specialist position at Online Technical Services, Inc.?
Our client is a successful manufacturer of medical devices.
We have a need for a temporary Quality Complaints person with experience with handling medical device complaints.
This is 100% onsite in San Diego
Contract is slated for 6 months but can be extended or hired
Please review the JD thoroughly before submitting your resume
Responsibilities :
- Monitor the Complaint Handling inbox regularly for new complaints and adverse event reports.
- Create and manage complaints in the eQMS (electronic Quality Management System), and input data into the Master Complaint Tracker.
- Attach relevant files and reports related to complaints in the eQMS, such as PC / AE reports, follow-up communications, reportability assessments, log files, etc.
- Organize and create complaint folders in SharePoint to facilitate investigation and collaboration activities.
- Perform DHR (Device History Record) reviews for complaint investigations.
- Update complaint investigation summaries with administrative details, including complaint number, PC / AE report information, device information, etc.
- Generate log files and attach them to both the eQMS and SharePoint complaint folders.
- Track handpiece returns inventory and submit weekly requests to the 3PL (third-party logistics) provider for return shipments.
- Knowledge of QSRs (Quality System Regulations) and their application.
- Experience in complaint handling.
- Ability to work proactively and collaborate with managers and operational teams to resolve quality issues.
- Strong time management skills, with the ability to handle multiple tasks and maintain self-motivation.
- Excellent written, verbal, and interpersonal communication skills in English.
- Proficiency in Microsoft Word, Excel, and SharePoint.
Required Skills :
