Position Overview
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
- Handle cus...