Quality Assurance Engineer

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