EXECUTIVE / ENGINEER - QUALITY ASSURANCE, COMPLAINT HANDLING

Job Description

OVERVIEW

• Assist QA-Manager to handle customer complaints and shipment failures in a timely manner and to maintain complaint files (external and internal) as per quality standard, customers and regulatory requirements.

DUTIES AND RESPONSIBILITIES

• Facilitate and monitor customer complaints investigation in accordance with complaint handling procedure.
  • Ensure customer complaint / feedback received is logged and investigation being conducted timely.
  • Plan and lead internal discussion with respective process owners on the customer complaint/ feedback received.
  • Issuance of Corrective Action/ Preventive Action (CAPA) request and ensure close follow-up with process owners for the complete CAPA submission within the lead time set.
  • Prepare the report / response letter for QA-Manager and QA- Senior Manager / Deputy General Manager’s review and approval; and submission of approved report to Sales / Customer within the required lead time.
  • Ensure complaint log and relevant documentation are maintained and updated.
• Facilitate and monitor shipment failures investigation through CAPA system.
  • Ensure shipment failures received is logged and investigation being conducted timely.
  • Plan and lead internal discussion with respective process owners on the shipment failures received.
  • Issuance of Corrective Action/ Preventive Action (CAPA) request and ensure close follow-up with process owners for the complete CAPA submission within the lead time set.
  • Ensure shipment failure log and relevant documentation are maintained and updated.
• Manage and monitor Corrective and Preventive actions with respect to the CAPA Procedure.
  • Ensure that the CAPA issued are being followed-up and all actions taken is completed within the promised dateline
  • Verify the completeness and the effectiveness of the corrective actions within the timeframe with proper evidence keeping.
  • Ensure CAPA and all supporting documents are maintained.
• Drive analysis of complaint and shipment failures data for improvement
  • Ensure customer complaint/ feedback and shipment failure information is properly logged and accurately categorized for analysis.
  • Utilize QC tools e.g. Pareto analysis, trend chart in identifying target area for improvement.
  • Compile and present analysis for management review in driving improvement actions.
• Assist QA- Manager in reviewing and updating complaint handling procedures to ensure its accuracy, suitability and effectiveness.
• Escalate all unresolved issues to Manager for further action, whist keeping process owner informed.
• Ensure proper updating and up keeping of department required quality records.
• Assist in undertaking and managing regulatory, customer, internal and external audits.
• Any other tasks assigned by superior

REQUIREMENTS

Education:

• Bachelor Degree in Science.

Work Experience:

• Preferably with 1 year of working experience in manufacturing environment.

Technical and Professional Knowledge:

• Work planning and scheduling.
• Good Communication Skills in both verbal and written, clear and easy to understand and include listening skills. (Both English and Bahasa Malaysia).

Certification / License Requirement:

N/A