Position:

PMQA – Complaints Analyst

Experience:

10+ Years

Industry:

Medical Devices

Key Responsibilities:

- Perform retrospective reviews of historical complaint records and complaint investigations.

- Assess complaint files for accuracy, completeness, and compliance with established protocols.

- Identify and escalate Potential Adverse Events and other compliance concerns.

- Support FDA CAPA activities, post-market surveillance, and remediation initiatives.

- Collaborate with Quality, Regulatory, Clinical, and Engineering teams to ensure regulatory compliance.

- Document findings, identify gaps, and support process improvement activities.

Required Skills:

- 10+ years of experience in complaint handling, complaint investigations,



or post-market quality within the medical device industry.

- Robust knowledge of FDA regulations, CAPA, quality systems, and complaint management processes.

- Experience with retrospective reviews, remediation projects, and complaint documentation.

- Excellent analytical, documentation, and communication skills.

- Experience working in cross-functional quality and regulatory environments.

Preferred Skills:

- Experience with FDA inspection remediation activities.

- Knowledge of Potential Adverse Event assessments.

- Familiarity with Post Market Surveillance processes.

📌 PMQA – Complaints Analyst (Hyderabad)
🏢 Intellectt
📍 Hyderabad