Engineer 1, Quality System

Smith & Nephew

Penang, Malaysia
Quality management system (qms) operation
Qms maintenance and implementation
Quality audits leadership
This role is responsible for operating the Quality Management System (QMS) and ensuring that it is maintained and implemented effectively

Job Summary

  • This role is responsible for operating the Quality Management System (QMS) and ensuring that it is maintained and implemented effectively.
  • The position ensures ongoing QMS inspection readiness by coordinating preparation for external inspections and audits, conducting training on QMS principles for relevant functional areas, and identifying opportunities for continuous improvement.
  • The role also supports HSE, sustainability, and energy policies by preventing safety and health injuries, environmental pollution, and energy wastage.

Matching Summary

This role is responsible for operating the Quality Management System (QMS) and ensuring that it is maintained and implemented effectively.

Skills & Requirements

Must-have

  • Quality Management System (QMS) operation
  • QMS maintenance and implementation
  • Quality audits leadership
  • Medical device regulations understanding
  • CAPA process management
  • Change control management

Nice-to-have

  • Continuous improvement identification
  • Technical innovation facilitation
  • HSE compliance and reporting
  • Team collaboration and communication

Key Requirements

  • Bachelor’s degree in Science, Engineering, Math, Business
  • Minimum three years’ experience in Quality Engineering/Systems/Assurance
  • ISO 13485 lead auditor certification desirable
  • Internal auditing experience preferable

Work Rights

Not specified

Tailored Resume

Cover Letter