Quality Engineer 1

Job Description

• Responsible for overall management of Process Validation Program, Stability Program and PFMEA program.
• Coordinate, monitor and execute the Process Validation Program and Stability Program for Bard Sdn.
• Ensure compliance to BD Corporate procedure, Division procedure, and Bard Sdn. Bhd. procedure.
• Act as a validation independent reviewer and technical independent reviewer for process validation protocol and report. Review process validation data generated and perform statistical analysis where appropriate.
• Serve as change control coordinator for the site change project.
• Perform gap analysis against the BD Corporate Procedure, Divisional Operating Procedures and Corporate Policy and update local procedures accordingly.
• Maintain and update, when necessary, all BOPs for Process Validation, PFMEA, Software Validation Program, Finished Product Testing and Stability Program.
• Act as proto...