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

. Conduct internal audits and follow up CAPA

. Support external certification audits

. Handle customer audits and responses

. Perform supplier audits and qualification

• Regulatory Compliance

. Ensure compliance with FDA, EU, China GB requirements.

. Support documentation such as DoC, SDS, and reports.

• Management Review & Improvement

. Prepare management review data and reports.

. Drive continuous improvement and Lean initiatives.

• Customer Management

. Handle customer complaints and quality communication.

• People Management

. 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 :

1. QMS standards (ISO 9001, ISO 22000, ISO 13485)

2. GMP, GDP, and regulatory frameworks

3. SPC, FMEA, CAPA

4. Root Cause Analysis (8D)

5. Data analytics and reporting

6. Good understanding of manufacturing processes

7. Strong communication and audit handling skills

8. Ability to lead cross-functional teams