Quality Specialist 1

2/1/2026

The Quality Specialist 1 will perform document control activities, quality system audits, and customer complaint investigations. They will also ensure thorough evaluation of complaint samples and maintain a systematic filing system for controlled documents.

Working Hours

40 hours/week

Company Size

501-1,000 employees

Language

English

Visa Sponsorship

About The Company

BD is one of the world's largest medical technology companies that produce and sell medical equipment, medical systems and reagents, dedicated to improving human health around the world. BD focuses on improving drug treatment, improving the quality and speed of diagnosis of infectious diseases, and promoting the research and discovery of new drugs and vaccines. BD has strong research and development capabilities to fight many of the world's most intractable diseases. Founded in New York in 1897, the company is headquartered in Franklin Lake, New Jersey, USA and employs more than 25000 people in about 50 countries around the world. The company's clients include medical institutions, life sciences research institutes, clinical laboratories, industrial units and the general public.

About the Role

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

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Additional Locations

Work Shift

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

Key Skills

Document ControlQuality System AuditComplaint InvestigationRoot Cause AnalysisComplaint HandlingFiling System MaintenanceConfidentialityProject AssistanceDevice History Records