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.
Education and Experience:
1. Minimum Diploma or Degree in Science stream and equivalent.
2. Minimum 1-3 years working experience in manufacturing sector.
3. Experience in problem solving methodology.
4. Experience in collaboration with cross-functional team.
5. Industrial quality assurance experience is an asset though not a pre-requisite.
Required Skills
Optional Skills
.