Quality Engineer 1

BD · kulim, kedah, Malaysia

Location
kulim
Job Type
Full-time
Posted
June 04, 2026

Job Description

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...

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