JOB DESCRIPTION SUMMARY

Plan, co-ordinate and oversee all QA support activities and initiatives in the work cell. To improve process capabilities and product quality to meet the desired targets.

JOB DESCRIPTION

• Oversee the product quality from assembly to packaging process and ensure full compliance to the Quality System and regulation requirements.
• Champion data-driven decisions to resolve non-conformances, complaint investigation, CAPA, deviation and other quality matters in a timely manner.
• Interfaces with R&D, unit quality, customer quality engineer to formulate plans and actions to meet product specifications and quality requirements
• Drive quality improvement/automation projects through project planning, scheduling inspection/testing activities, performing analysis and publishing reports.
• Perform test method validation, installation qualification, correlation study for new quality equipment/test method.
• Act as a support role for regulatory, external, internal and/or supplier audits and lead the value stream members to execute the corrective actions for compliance with customer specifications.
• Perform data analysis and trending for product quality performance through monthly and quarterly management review meeting.
• Establish and maintain effective system and procedures to ensure that all manufacturing and engineering documentation are controlled and updated per established regulatory requirements.
• Supervise quality technical specialist and a group of technicians on quality tests and checks.
• Safety & ISO 14001 Environmental accountability: Ensure a safe, healthy and environmentally-friendly workplace by observing Company’s rules and procedures. Active involvement in prevention, elimination of potential safety hazards and participation in activities which promotes recycling, replacement and reduction of resource materials.
• Perform any other tasks as assigned.

PREFERRED REQUIREMENTS

• 3 years relevant working experiences in a quality engineer role will be advantageous.
• Demonstrated good understanding of key elements of Quality Management system, CFR Part 820, ISO 13485.
• Preferably possess Six Sigma Green-Belt certification or knowledge on six sigma tools.
• Able to effectively multi-task and work independently with a high level of initiative
  Required Skills
  Optional Skills
  .

Please refer the Job description for details