I'm helping qvalfocus.com find a top candidate to join their team full-time for the role of Remediation Complaint Analyst – Medical Devices. You will ensure patient safety and product quality by leading critical complaint investigations. Compensation: INR 10 - 15/year Location: Remote (anywhere) Mission of qvalfocus.com: "Our mission is to help regulated organizations achieve operational excellence and compliance through expert guidance, structured execution, and reliable solutions that ensure quality, clarity, and lasting performance." What makes you a strong candidate: You have +6 years experience in Quality assurance (QA). You are proficient in Technical documentation, Regulatory compliance, Data analysis, Complaint management. English - Conversational Responsibilities and more: Job Summary: The Complaint Analyst is responsible for the intake, review, investigation, and documentation of product complaints in accordance with applicable regulatory requirements and internal quality procedures. This role supports the post-market surveillance process by ensuring timely evaluation,



investigation, and closure of complaints while maintaining compliance with FDA regulations, ISO 13485, and other applicable quality system requirements. Key Responsibilities: Review, document, and process product complaints received from customers, field service teams, and distributors. Perform complaint intake and ensure accurate documentation of complaint details within the complaint handling system. Conduct initial complaint assessments to determine severity, reportability, and investigation requirements. Perform complaint investigations including review of device history records, service records, and failure data. Support the determination of Medical Device Reporting (MDR) or regulatory reporting requirements when applicable. Code complaints using appropriate complaint classification systems (e.g., IMDRF coding). Coordinate with cross-functional teams including Quality, Regulatory Affair

📌 Remediation Complaint Analyst (Ciudad de México)
🏢 Emma of Torre.ai
📍 Ciudad de México