ENGINEER, QUALITY (QMS)

Overview

Support the Quality Manager to establish and maintain an effective quality management system and processes in compliance to various quality management system standards, meeting customers as well as relevant statutory and medical device regulatory requirements.

Key responsibilities

• Maintain and improve Quality Management Systems.
• Monitor product and process quality to ensure compliance with specifications and customer requirements.
• Conduct internal audits and support external audits by customers, certification bodies, and regulatory agencies.
• Lead investigations, root cause analysis, corrective actions, preventive actions (CAPA), and continuous improvement activities.
• Review quality data, identify trends, and recommend improvement actions.
• Handle customer complaints and quality-related issues, including preparation of 8D/PDCA reports.
• Liaise with suppliers, customers, and internal teams on quality matters.
• Control non-conforming products and support containment activities when quality issues arise.
• Maintain quality documentation, records, procedures, work instructions, and training programs.
• Support QC Inspectors and Technicians in inspection and quality-related activities.

Qualification

• Diploma or Degree in Engineering, Quality Management, or related technical discipline.
• Minimum 1-3 years of experience in Quality Assurance, Quality Control, or Quality Management System functions.
• Experience in medical devices, manufacturing, or regulated industries is advantage.
• Familiar with relevant standards and regulations (e.g., ISO 9001, IATF 16949, ISO 13485, GMP).
• Strong problem-solving, analytical, and root cause analysis skills.
• Good written communication and interpersonal skills.