Senior / Lead Quality Assurance Engineer

Job Title: Senior / Lead Quality Assurance Engineer
Job Description
The Senior / Lead Quality Assurance Engineer coordinates and oversees batch record review and related production quality activities to support compliant and efficient medical device manufacturing operations. This role serves as the primary lead for Device History Record (DHR) and batch record review coordination, product release support, review prioritization, issue escalation, and cross-functional alignment with Manufacturing, Quality Engineering, Quality Control, Materials Management, and Operations. The position provides technical leadership, mentorship, and operational coordination to ensure inspection readiness, continuous improvement, and right-first-time execution across manufacturing quality processes, while maintaining adherence to domestic and international quality system standards and regulations.
Responsibilities

+ Coordinate and oversee batch record review and associated production qualit...

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