Quality Engineer (Qualification)

Job Description Summary

Refer to JD-QA-067 for Quality Engineer (Qualification Engineering).

• Report to the Unit Manager. Plan, organize, and coordinate the validation and qualification activities. Provide leadership to subordinates. Support analysis of manufacturing and materials quality issues using appropriate QA tools.
• Plan and coordinate the facility process validation program, stability program, and PFMEA program. Also, in charge of the component qualification, accelerated aging, ship testing, and packaging validation.
• Assist the Unit Manager of Quality Engineering in monitoring Quality Audit activities and attending to external audits.

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. Bhd. to ensure compliance with BD Corporate procedure, Division procedure, and Bard Sdn. Bhd. procedure.
• Be a validation independent reviewer and technical independent reviewer for process validation protocol & report. Review process validation data generated and perform statistical analysis where appropriate.

Required Skills

Optional Skills

Primary Work Location: MYS Kedah - Bard Kulim (Malaysia)

Additional Locations:

Work Shift: MY3 Normal 8a-4.45p Group 26 (Malaysia)

• Bidang tugas

  Jaminan Kualiti

• Industri

  Pembuatan Peralatan Perubatan