ENGINEER / EXECUTIVE - QUALITY ASSURANCE, PSI

Job Description

OVERVIEW

• To assist Manager to oversee and manage final inspection activities, incoming packaging and containers, and calibration activities to ensure that procedures and work instructions are being implemented accordingly.
  
  

DUTIES AND RESPONSIBILITIES

• Check, identify and report on any deviations in procedure and work instruction against actual practice in Pre shipment section.
• Review related quality system procedures and work instructions for pre-shipment. Ensure the documents are kept updated and implemented successfully at work area including issues related to Safety and Health.
• Ensure all Pre-shipment inspections are planned, coordinated and conducted as per specified in work procedure
• Investigate and report on failure of pre-shipment inspections. Record, compile and analyse pre - shipment failures
• Review to ensure correctness and on-time submission of final inspection reports to related parties.
• Responsible to ensure correct implementation of Incoming Packaging Materials inspection as per Work procedure.
• To liaise with relevant departments and supplier on any problem related to packaging materials.
• Responsible to implement CAPA system in relation to shipments failure and incoming packaging materials failure.
• Plan and schedule work for pre-shipment activities to ensure proper distribution of assignments and adequate manpower.
• Plan and conduct meeting with subordinates to ensure compliance with established practices, and to keep employees abreast of current changes and standards.
• Supervising pre-shipment staff in carrying out tests and inspection with the assistance of Supervisors (Final inspections and packaging material inspection)
• Assist in conducting company Internal Quality Audit as per Internal Audit Procedure.
• To provide training and guidance to subordinates in regards to daily activities and identified training needs
• Ensure Safety and monitor the performance, attendance and discipline of PSI personnel with assistance of supervisor
• Provide Medline waive inspection report to customer.
• Provide Microflex report to customer.
• Provide Medipart report to customer.
• Provide physical properties report to Medline.
• Prepare rework report (Halyard and Medline).
• Follow up pending Medline inspection report from Medline Inspector.
• Update product spec and other PSI related document.
• Review and approve SGS and Microflex external inspection report.
• Draft Halyard SCAR response.
• Attend kick-off meeting sales/purchasing.
• Attend issue highlighted by external inspector.
• Attend issue highlighted by PSI supervisor and subordinate.
• Draft PSI CAPA response (Audit, Complaint, un-schedule CAPA) and prepare supporting evidence.
• Support additional request by management.
• Draft employee of the month.
• Kaizen issuance.
• Issuing shipment failure CAPA.
• Issuing Supplier CAPA.
• Review PSI report before provide to managers.
• Monitor PSI activity, update PSI master plan.
  
  

REQUIREMENTS

Education:

• Bachelor Degree in Science or any related field or Diploma in Science with at least 2 years of working experience.
  
  

Work Experience:

• Minimum 2 years of working experience or fresh graduate with similar roles and responsibilities.
  
  

Technical and Professional Knowledge:

• Quality control and troubleshooting tools and techniques.
  
  

Certification / License Requirement:

• N/A