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 :

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

Relevant engineering experience with strong technical competency

Singapore experience preferred for senior engineering roles

Technically and digitally competent with exposure to engineering technologies, automation, AI-assisted tools, and digital applications

Demonstrates curiosity to learn, evaluate, and apply new technologies to improve engineering performance and efficiency

Leads Root Cause analysis (RCA) and implements Corrective And Preventive Actions (CAPA) to improve

Requipment reliability and process performance

Prepares technical documentation, engineering reports, and Standard Operating Procedures (SOPs) while ensuring compliance with safety and quality standards

Analytical and forward-thinking with proactive problem-solving skills and continuous improvement mindset

Demonstrates professionalism, technical discipline, high sense of urgency in escalating issues, and effective collaboration across teams