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

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