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Senior QM R&D Engineer I

Ambu
Penang, Malaysia
2-4 Years
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Job Description

Responsibilities

  • Participate in new product development and project design change for global products.
  • Participate and provide independent oversight on project/ design changes deliverables; review and ensure that project/validation documents comply to regulatory requirements and quality.
  • Handle change control, especially be the expert in process validation for global products.
  • Participate in the critical quality issue which required QAE attention in the project as required.
  • Involve in NCR/ CAPA activities as required.
  • Maintain the Risk Management files and initiate Process Risk Evaluation during new platform project/ design change.
  • Other QM R&D function, as identified.

Requirements

  • Degree in science or equivalent.
  • Min 2 years in Quality Assurance or Quality Engineering.
  • Knowledge in ISO13485 and ISO14971.
  • Experience in product development, project management and/or design control.
  • Innovative, committed with good accountability.

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Quality Assurance
Employment Type:
Full time

About Company

Ambu

Job ID: 149612735

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Last Updated: 23-06-2026 06:33:31 AM
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