jobs in Ambu A/S

Kerja Sepenuh Masa, Senior QM R-D Engineer I di Ambu A/S Pulau Pinang - Maukerja

Senior QM R-D Engineer I

Ambu A/S

Undisclosed

Sepenuh Masa

Pulau Pinang

Kongsi
Simpan

Lokasi Kerja

  • Pulau Pinang Malaysia

Penerangan Kerja

Tanggungjawab

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.
  • Experience in product development, project management and/or design control.
  • Innovative, committed with good accountability.

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