Quality Management Engineer (QM)

Job Purpose:

Coordinate and Maintain all (re)validation activities for all processes of Plant.

Tasks & Responsibility

1. Qualification & Validation

• Responsible for making (Re)validation protocols/reports

• Coordinate with related department to commit with expected validation timeline

• Involve and perform validation during Change control activity

• Involve and perform validation during Project execution

• Follow requirement of local/global SOP for (re)validation process and share with local team

2. Risk assessment

• As team member for Process risk analysis

• As team member for Equipment risk analysis

• Understand and share risk analysis concept to related departments: Method, Action, Requirements…

3. Other tasks

• Create/revise local SOP according to requirement in global SOP/ ISO/ regulations

• Perform training/sharing SOP for Production/ QC/ IE to follow up.

• Make the training plan for new member/FSU and accompany them during development program

Qualification Requirements

1. Education

• Bachelor degree in Technical background.

• Nice to have ISO 13485, ISO 9001, ISO 11135, ISO 11607.

2. Working Experience

• Have at least 2-year working experience and knowledge in Validation

• Risk management/ Risk analysis method

3. Nice to have:

• ETO Validation sterilization process

• Validation for Medical device manufacturing process

4. Skills required:

• Good command in English, Presentation and Communication

• Communication

• MS Office

• Presentation

• Team work