Complaint Analyst Post-Market Quality Analyst
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Job Location:
Newark, DE - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Title : Complaint Analyst / Post-Market Quality Analyst
Location : 100% Remote
Long Term Contract
Experience: 7 years preferred
Multiple Openings
Role Summary:
We are seeking a Complaint Analyst to support Post-Market Quality activities by investigating product complaints evaluating potential adverse events and
supporting complaint closure within the Quality Management System.
The role involves analyzing field complaints supporting product investigations and ensuring complaint handling activities comply with FDA and ISO medical
device quality regulations.
Key Responsibilities:
Complaint Investigation
Assess incoming product complaints and determine applicable failure modes.
Evaluate complaints to identify potential adverse events and escalate when required.
Perform detailed complaint investigations and document findings in the Quality Management System.
Complaint Processing
Ensure complaints are reviewed investigated and closed within required timelines.
Maintain complete and compliant complaint documentation.
Product Evaluation
Support testing and evaluation of returned products associated with customer complaints.
Identify potential product issues and support root cause analysis.
Risk Evaluation
Apply risk-based decision making using tools such as:
o FMEA
o Fault Tree Analysis (FTA)
o Risk evaluation methodologies.
Post-Market Surveillance Support
Provide input to Post-Market Surveillance teams regarding complaint trends and product performance.
Support complaint trending and quality metrics.
Quality System Support
Support investigations including:
o CAPA
o Non-Conformance Events (NCE)
o OOT investigations
o similar quality events.
Cross-Functional Collaboration
Work with Manufacturing Quality Engineering R&D Regulatory Affairs and Clinical teams to resolve product issues.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
Yes
Employment Type :
Contract
Key Skills
- Microsoft Access
- SQL
- Analysis Skills
- Microsoft Powerpoint
- Securities Law
- Data Mining
- Investment Banking
- Market Research
- Microsoft Excel
- Visual Basic
- Bloomberg
- Data Analysis Skills
About Company
At Fusion Plus Solutions Inc, we believe that it’s an exceptional company - a company of people proud of the work they do and the solutions they provide. By understanding what drives our specialty industries, becoming involved in our communities on a professional and personal basis, f ... View more
