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:
· Establish and maintain QA inspection procedures
· Manage non-conformance and corrective actions (8D, RCA)
· Perform SPC, trend analysis, and risk assessment (FMEA)
· Maintain ISO 9001, ISO 22000, ISO 13485 systems
· Ensure GMP, GDP compliance
· Control SOPs and documentation
· Conduct internal audits and follow up CAPA
· Support external certification audits
· Handle customer audits and responses
· Perform supplier audits and qualification
· Ensure compliance with FDA, EU, China GB requirements.
· Support documentation such as DoC, SDS, and reports.
· Prepare management review data and reports.
· Drive continuous improvement and Lean initiatives.
· Handle customer complaints and quality communication.
· Train and supervise QA Inspectors
· Manage QA Engineers (For Senior QA)
Requirement
Degree in Engineering (Mechanical, Materials, Chemical, or related field)
Certified Internal Auditor (ISO 9001 / ISO 22000 / ISO 13485)
Certified Quality Engineer (CQE) or equivalent
Minimum 2–5 years (QA Engineer)
Minimum 5–8 years (Senior QA Engineer, with leadership experience)
Experience in manufacturing (packaging, food, medical, or related industries preferred)
Preferably able to start work immediately or at short notice
Strong knowledge of :
QMS standards (ISO 9001, ISO 22000, ISO 13485)
GMP, GDP, and regulatory frameworks
SPC, FMEA, CAPA
Root Cause Analysis (8D)
Data analytics and reporting
Good understanding of manufacturing processes
Strong communication and audit handling skills
Ability to lead cross-functional teams
