Process Engineer - Medical Devices & Process Improvement

Ensera Group; Klang City; On-site; MYR 44,640 - 66,960; Full time

Job summary

A leading manufacturing company in Klang City is seeking a Process Engineer to manage qualification activities for production processes. The successful candidate will analyze equipment-related downtimes, coordinate with vendors, and lead process improvements. Applicants should have a degree in Engineering or Science, at least 2 years of experience in the manufacturing or medical industry, and proficiency in ISO 13485 and GMP standards. Strong leadership and communication skills are essential for this role.

Qualifications

• Minimum 2 years’ working experience in manufacturing or medical industry.
• Knowledge of ISO 13485 and GMP is an advantage.
• Good written and spoken English and Bahasa Malaysia.

Responsibilities

• Review and update routing and product structure related to Production processes.
• Analyze unplanned downtime and propose improvement plan.
• Manage coordination activities with vendors for process equipment.

Skills

Leadership

Problem-solving

Communication

Analytical skills

Education

Degree in Engineering or Science

Tools

Microsoft Office

Job description

A leading manufacturing company in Klang City is seeking a Process Engineer to manage qualification activities for production processes. The successful candidate will analyze equipment-related downtimes, coordinate with vendors, and lead process improvements. Applicants should have a degree in Engineering or Science, at least 2 years of experience in the manufacturing or medical industry, and proficiency in ISO 13485 and GMP standards. Strong leadership and communication skills are essential for this role.