Quality Specialist 1

Job Description Summary

Job Description Summary
To support Silicone Catheter complaint Investigation Evaluation and reporting.

Job Description

P1-14199

Job Responsibilities: (Primary Duties, Roles, and/or Authorities)
1. Perform document control activities, Quality System Audit activities, PEM, FI and CAPA
administration of Bard Sdn. Bhd. and issue monthly report per procedure.
2. Communicate changes/distribution of controlled documents to recipients and maintain all master
and distributed documents in a state of control.
3. Perform customer complaint investigations according to BOP, DOP and corporate QA guideline.
4. Responsible to ensure complaint samples are evaluated thoroughly and analyze using correct
technique and able to provide appropriate root cause of defective products.
5. Perform complaint handling activities and ensure in maintaining of complaint room and all
equipment in the room.
6. Maintain a systematic filing system for all controlled documents and correspondences under the
responsibility of the Senior QA Manager.
7. Ensure that all controlled documents are handled with confidentiality and stored securely.
8. Assist the QE QMS/QMS Manager) in carrying out any special project or assignment.
9. Perform the compilation and retention of all Device History Records in a timely manner.

Required Skills

Optional Skills

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Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

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