Job Description
Descripción y detalle de las actividades
The Quality Assurance Engineer will be responsible for supporting and maintaining the Quality Management System (QMS) in alignment with ISO 13485 and other applicable standards, ensuring compliance with both regulatory and customer-specific requirements in the medical device industry.
This role is essential for maintaining product quality across the lifecycle, preparing for and supporting audits, and driving continuous improvement initiatives. The engineer will collaborate with internal teams and external bodies to uphold Luxshare’s commitment to quality and compliance.
This position is critical for the business due to the following reasons:
- Ensure compliance with the Quality Management System, in accordance with Luxshare QMS, applicable standards, for example ISO 13485 and FDA 21 CFR Part 820 and Other medical standards.
- Assist in the development, implementation, and improvement of quality procedures, work instructions, and f...
The Quality Assurance Engineer will be responsible for supporting and maintaining the Quality Management System (QMS) in alignment with ISO 13485 and other applicable standards, ensuring compliance with both regulatory and customer-specific requirements in the medical device industry.
This role is essential for maintaining product quality across the lifecycle, preparing for and supporting audits, and driving continuous improvement initiatives. The engineer will collaborate with internal teams and external bodies to uphold Luxshare’s commitment to quality and compliance.
This position is critical for the business due to the following reasons:
- Ensure compliance with the Quality Management System, in accordance with Luxshare QMS, applicable standards, for example ISO 13485 and FDA 21 CFR Part 820 and Other medical standards.
- Assist in the development, implementation, and improvement of quality procedures, work instructions, and f...
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