Quality Specialist 1

BD; Kulim; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading healthcare company in Kulim, Malaysia, is seeking a Quality Engineer to assist in document control activities and quality system audits. The role involves managing controlled documents, performing complaint investigations, and supporting the Senior Quality Manager. Ideal candidates have a Diploma or Degree in Science and experience in the manufacturing sector. This role offers the opportunity to collaborate in a dynamic team environment.

Qualifications

• Minimum 1-3 years working experience in manufacturing sector.
• Experience in problem solving methodology.
• Industrial quality assurance experience is an asset.

Responsibilities

• Assist the Quality Engineer QMS in document control activities.
• Perform customer complaint investigations according to corporate QA guideline.
• Maintain a systematic filing system for all controlled documents.

Skills

Document control

Quality system audit

Problem solving

Collaboration with cross-functional teams

Education

Diploma or Degree in Science

Job description

Job Description Summary

Assist the Quality Engineer QMS in document control activities, managing Quality System Audit activities and Compliance Coordinator.

Exercise control on all documents generated at BD Kulim, which are classified as Controlled Documents.

Responsible for the issuance and retrieval of all controlled documents generated by the facility and distributed to BD from external source. Assist Senior Quality Manager in clerical and administrative duties.

Job Description

Job Responsibilities

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

Education And Experience

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

Primary Work Location

MYS Kedah - Bard Kulim (Malaysia)

Work Shift

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