We are looking for Quality Assurance & Documentation Executive who will be responsible for maintaining quality management system (QMS) documentation, ensuring compliance with applicable regulatory requirements, and supporting quality control activities within the organization.
Core Responsibilities:
Preparation and control of:
SOPs
Work Instructions
Quality Manuals
Technical files
Device Master Records (DMR)
Batch Manufacturing Records (BMR)
Maintaining ISO documentation (e.g., ISO 13485 if medical devices)
Handling audits (internal & external)
CAPA documentation
Vendor qualification records
Calibration and validation documentation