Job Description Summary

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

• 1-2 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

What In It For you

• Competitive full‑time compensation package and benefits

• Paid company holidays (public holidays, rest days, etc.)

• Opportunities for career development and growth

• Convenient company transportation provided

Required Skills

Optional Skills

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Primary Work Location

Additional Locations

Work Shift