QMS Engineer

Vital; Malaysia; Hybrid; MYR 50.000 - 80.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

Communication skills

Coordination

Interpersonal skills

Ausbildung

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

Jobbeschreibung

• 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.

Job Requirement

• Bachelor's Degree in Quality Management, Engineering, Manufacturing, Industrial Management, or related discipline.
• Familiarity with related ISO standard and/or GMP requirements
• Experience in document review, document control, or quality management systems (QMS) will be an added advantage
• 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.