The posting
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



