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