Job Summary The Complaints Specialist is responsible for supporting the review, investigation, documentation, and resolution of product complaints within a regulated industry setting. The role involves evaluating complaint information, maintaining accurate records, coordinating with internal teams, and ensuring complaints are processed in accordance with quality and regulatory requirements.

Key Responsibilities

- Review and assess product complaints received from customers, patients, or other sources.
- Enter, document, and maintain complaint records accurately in the applicable complaint management system.
- Perform initial complaint assessments and determine appropriate follow-up or investigation requirements.
- Coordinate with Quality, Regulatory, Engineering, Manufacturing, and other cross-functional teams during complaint investigations.
- Review supporting documentation, product information, and investigation findings.
- Track complaint investigations and ensure required actions are completed within established timelines.
- Support preparation of complaint reports, investigation summaries, and related quality documentation.
- Identify potential trends or recurring complaint issues and escalate concerns as required.
- Maintain compliance with applicable company procedures,



quality systems, and regulatory requirements.
- Ensure complaint records are complete, accurate, and audit-ready. Basic Qualifications
- Bachelor’s Degree and 2 years of relevant experience; OR
- Associate’s Degree and 4 years of relevant experience; OR
- High School Diploma or equivalent and 6 years of relevant experience.
- Experience in complaints, quality, customer quality, post-market surveillance, or a related regulated-industry function.
- Strong documentation, analytical, communication, and organizational skills.
- Ability to work effectively with cross-functional teams. Preferred Experience
- Experience in Medical Device, Pharmaceutical, Biotech, or other regulated industries .
- Familiarity with complaint handling and quality management systems.
- Experience with investigations, CAPA, nonconformances, or post-market quality processes.
- Experience working with electronic quality or complaint management systems. Key Skills Complaint Handling | Complaint Investigation | Quality Systems | Documentation | Regulatory Compliance | CAPA | Nonconformance | Post-Market Quality | Cross-Functional Coordination | Data Analysis

📌 Complaints Specialist (India)
🏢 Fusion Life Sciences Technologies
📍 India