QMS Engineer
About the role
Job description:
Maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulatory requirements.
Manage and control quality documentation, including procedures, work instructions, forms, and records.
Plan, conduct, and coordinate internal and external quality audits.
Lead investigations of non-conformities, customer complaints, and quality issues through root cause analysis and CAPA implementation.
Monitor the effectiveness of corrective and preventive actions to ensure continuous improvement.
Support management review activities and quality performance reporting.
Ensure compliance with company policies, quality standards, and regulatory requirements.
Coordinate employee training related to quality systems and procedures.
Requirements
Bachelor's Degree in Engineering, Quality Management, Manufacturing, or related field.
Minimum 3 years of experience in Quality Management Systems within a manufacturing environment.
Experience in medical device manufacturing is highly preferred.
Strong knowledge of ISO 13485, CAPA, document control, and audit processes.
Experience conducting internal audits and handling external audits.
Familiar with root cause analysis tools such as 5 Why, Fishbone Diagram, and 8D methodology.
Good understanding of regulatory and quality compliance requirements.
Support customer, certification body, and regulatory audits.
Work closely with cross-functional teams to drive quality improvement initiatives.
Pay: RM3,000.00 - RM7,000.00 per month
Benefits:
Opportunities for promotion
Professional development
Work Location: In person
Questions about this role
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