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

1. Establish and maintain QA inspection procedures
2. Manage non-conformance and corrective actions (8D, RCA)
3. Perform SPC, trend analysis, and risk assessment (FMEA)

• QMS & Compliance

1. Maintain ISO 9001, ISO 22000, ISO 13485 systems
2. Ensure GMP, GDP compliance
3. Control SOPs and documentation

• Audit Management

1. Conduct internal audits and follow up CAPA
2. Support external certification audits
3. Handle customer audits and responses
4. Perform supplier audits and qualification

• Regulatory Compliance

1. Ensure compliance with FDA, EU, China GB requirements.
2. Support documentation such as DoC, SDS, and reports.

• Management Review & Improvement

1. Prepare management review data and reports.
2. Drive continuous improvement and Lean initiatives.

• Customer Management

1. Handle customer complaints and quality communication.

• People Management

1. Train and supervise QA Inspectors
2. 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