Quality Assurance Engineer

Full-time Quality Engineering

Job Summary / Purpose

• Lead and maintain Quality Management System (QMS) aligned with ISO 9001, ISO 22000, ISO 13485
• Ensure compliance with GMP, GDP, FDA, EU regulations, China GB and other applicable standards
• Drive quality assurance across incoming, in-process & outgoing controls
• Support audits, regulatory compliance, and customer requirements

Responsibilities and Accountabilities

Quality Operations

• Establish and maintain QA inspection procedures
• Manage non-conformance and corrective actions (8D, RCA)
• Perform SPC, trend analysis, and risk assessment (FMEA)

QMS & Compliance

• Maintain ISO 9001, ISO 22000, ISO 13485 systems
• Ensure GMP, GDP compliance
• Control SOPs and documentation

Audit Management

• Conduct internal audits and follow up CAPA
• Support external certification audits
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