Engineer/Executive - QA, Preshipment

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.