Quality Systems Engineer: Audit-Driven QMS Specialist

Vital; Malaysia; Hybrid; MYR 50,000 - 80,000; Full time

Job summary

Vital in Kuala Lumpur seeks a Quality Assurance professional to review batch records, maintain QMS documents, and support audits. The role focuses on CAPA, NCR, and regulatory compliance in a medical device environment, with collaboration across departments to uphold quality standards.

The ideal candidate holds a Bachelor's in Quality Management or related field, understands ISO/GMP, and has strong communication and organizational skills to drive continuous improvement.

Qualifications

• Bachelor's degree in quality management, engineering, manufacturing, industrial management, or related discipline.
• Familiarity with related ISO standards and/or GMP requirements.
• Experience in document review, document control, or quality management systems (QMS) is advantageous.
• Prior experience in the medical device industry is preferred.
• Good communication, coordination, and interpersonal skills.
• Detail-oriented, well-organized, and able to uphold quality and compliance standards.
• Knowledge of CAPA and NCR processes.
• Experience participating in external & internal audits.
• Workshop management or on-site operational experience is an advantage.

Responsibilities

• Review and approve batch records before submission to the Document Control Center
• Maintain and revise departmental quality documents and SOPs.
• Conduct self-inspections and internal audits to ensure compliance with quality management system requirements.
• Track and verify the effectiveness of corrective actions arising from audit findings and non-conformities.
• Support and accompany external auditors during regulatory, customer, and certification audits.
• Prepare CAPA reports and monitor implementation progress.
• Coordinate and manage employee training programs and training records.
• Perform routine audits and spot checks of workshop records and batch documentation.
• Manage engineering change control processes from initiation through closure.
• Continuously improve departmental quality systems and oversee compliance with quality procedures and requirements.
• Perform any other duties assigned by the superior.

Skills

Communication skills

Coordination

Interpersonal skills

Education

Bachelor's Degree in Quality Management, Engineering, Manufacturing, Industrial Management, or related discipline

Job description

Vital in Kuala Lumpur seeks a Quality Assurance professional to review batch records, maintain QMS documents, and support audits. The role focuses on CAPA, NCR, and regulatory compliance in a medical device environment, with collaboration across departments to uphold quality standards.

The ideal candidate holds a Bachelor's in Quality Management or related field, understands ISO/GMP, and has strong communication and organizational skills to drive continuous improvement.