QA Specialist
Posted Updated
Description
Summary:
- Ensure QMS compliance by collecting, reviewing, analyzing, and evaluating quality data, and initiating corrective actions when necessary.
- Handle customer complaints and associated activities.
- Work cross-functionally to resolve quality-related issues.
Responsibilities:
- Maintain and continuously improve the Quality Management System in accordance with regulatory requirements.
- Communicate quality-related information with authorities and manufacturers.
- Coordinate with overseas manufacturers, production sites, and complaint handling units to verify investigation results, identify root causes, and implement CAPA.
- Provide support for Regulatory Affairs and Post-Market Surveillance activities.
- Assist other internal teams as needed.
Requirements
Requirements:
- Knowledge of PMD Act, including QMS, GVP, sales and repair licenses; familiarity with promotion codes is a plus.
- Bachelor’s degree or higher (science background preferred).
- Business-level English preferred.
- Minimum 2 years of experience as a quality assurance administrator for medical devices.