QMS Engineer (Medical Device)

EPS Malaysia; Ulu Tiram; On-site; MYR 60,000 - 90,000; Full time

Job summary

EPS Malaysia is seeking a Quality/QMS professional to manage the Quality Management System in alignment with customer requirements. You will work with Production, Engineering and others to resolve quality issues and support continuous improvement. The role requires a degree or diploma in Engineering or Quality Management, 3-5 years' experience in QMS/EMS or medical device manufacturing, and familiarity with ISO standards, CAPA and audit processes.

Qualifications

• Familiar with ISO 13485 / ISO 9001 and audit requirements.
• Experience with CAPA, NCR, 8D, RCA and problem-solving.
• Good analytical, communication and documentation skills.

Responsibilities

• Manage and maintain the QMS in line with company and customer requirements.
• Ensure compliance with ISO 13485 / ISO 9001 and related standards.
• Coordinate internal, customer and external audits.
• Monitor CAPA, NCR and corrective actions.
• Investigate quality issues and perform root cause analysis.
• Prepare and maintain quality documentation, procedures and records.
• Collaborate with Production and Engineering to resolve quality issues.
• Monitor quality performance and support continuous improvement.
• Ensure compliance with customer-specific quality requirements.
• Conduct training and awareness programs on quality procedures.

Skills

Analytical skills

Communication skills

Documentation skills

Education

Degree/Diploma in Engineering or Quality Management

Job description

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