Fusion Life Sciences Technologies (www.fusionlifesolutions.com ) is a WBE-certified Healthcare Staffing and Engineering Services provider supporting industries including Pharma, Medical Devices, Aeronautical, Supply Chain, Heavy/Light Industrial, Food & Beverage, and Automotive. We proudly partner with 120+ clients such as Johnson & Johnson, Haemonetics, Delta, Caterpillar, Artisan Chef, Baxter, and many more. Our wide network of consultants and contract-to-hire engineers brings deep expertise across Engineering, Technical, Administrative, Healthcare, Life Sciences, Blue Collar, Skilled Trades, IT, Software Development, Manufacturing, and Supply Chain sectors. What sets us apart is our AI-powered, in-house software's enabling us to source and screen top talent within hours. This ensures rapid response times, high-quality matches, and virtually zero attrition.

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.

All your information will be kept confidential according to EEO guidelines.