全职 QMS Engineer 工作, 薪水 up to MYR 8,000, EPS Ventures Johor 公司招聘中 - Ricebowl

• 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: RM4,000.00 - RM8,000.00 per month

Benefits:

• Opportunities for promotion
• Professional development

Work Location: In person