Complaint Specialist
Complaint Specialist
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
- Records and monitors complaints in a validated document management system
- Supports documenting and filing required adverse event reports with FDA within required timeframes
- Performs and documents results of routine assessments and failure analysis of returned devices
- Evaluates the complaints and determine the level and rationale for the investigation
- Performs complaint risk assessments
- Conducts complaint investigations and write investigation reports
- Ensures the proper storage of complaint samples
- Triages and initiates investigation requests with both internal team and external suppliers
- Notifies Senior Management of complaints with significant quality or compliance issues that might require a Field Action/Recall according to Nalus Incident Reporting Procedures
- Tracks closure of complaint investigations and associated CAPAs that may be generated as a result of the complaint
- Reviews complaints and conclusions from complaint investigations conducted by internal personnel
- Develops and maintains appropriate metrics measuring state and performance of complaint system
- Contacts the complainant as warranted to obtain additional complaint information
- 5 years within medical device industry preferred
- Bachelors degree preferred
- Basic competence with medical terminology
- Familiar with regulatory requirements of 21CFR820 and 21CFR803 & complaint reporting guidelines
- Proficient with Microsoft office applications
- Ability to work independently but guided by documented procedures with appropriate support
- Able to work effectively as part of a team
- Excellent attention to detail
Required Experience:
Unclear Seniority
Employment Type
Full Time
