Quality Assurance Specialist Role
4 days ago
We seek a highly motivated and experienced Quality Assurance Specialist to join our team.
In this role, you will be responsible for leading and managing quality-related activities, driving excellence, and ensuring compliance with ISO 13485 and regulatory requirements.
Main Responsibilities:
- Lead and manage root cause investigations, ensuring timely and effective CAPA implementation.
- Develop, implement, and maintain QMS procedures and policies, ensuring adherence to ISO 13485 and regulatory requirements.
- Conduct internal audits, identifying areas for improvement and driving quality enhancements.
- Provide technical support for quality-related matters, ensuring compliance and process control.
Key Requirements:
- Bachelor's degree in Engineering, Quality, or Life Sciences.
- 3+ years' experience in a medical device or regulated manufacturing environment.
- Proven experience with root cause analysis, CAPA management, and failure investigations.
- Strong understanding of quality engineering tools and principles.
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