QMS Engineer (Medical Device)

About the role

Manage and maintain the Quality Management System (QMS) in accordance with company and customer requirements. Ensure compliance with ISO 13485 / ISO 9001 and relevant quality standards. Work closely with Production, Engineering and other departments to resolve quality issues and support continuous improvement activities.

Key responsibilities

• Manage and maintain the Quality Management System (QMS) in accordance with company and customer requirements
• Ensure compliance with ISO 13485 / ISO 9001 and relevant quality standards
• Coordinate internal, customer and external audits
• Monitor and follow up on CAPA, NCR, corrective and preventive actions
• Investigate quality issues and perform root cause analysis
• Prepare and maintain quality-related documentation, procedures and records
• Work closely with Production, Engineering and other departments to resolve quality issues
• Monitor quality performance and support continuous improvement activities
• Ensure compliance with customer-specific quality requirements
• Conduct training and awareness programs related to quality procedures and requirements

About you

• Degree/Diploma in Engineering, Quality Management or related field
• Minimum 3-5 years of experience in Quality/QMS, preferably in EMS, medical device or manufacturing environment
• Familiar with ISO 13485 / ISO 9001, audit requirements and quality tools
• Experience in CAPA, NCR, 8D, RCA and problem-solving
• Good analytical, communication and documentation skills