QA Engineer

  • Pulau Pinang
  • Permanent
  • Full-time
  • 1 month ago
Responsibilities Support Change Control/ DCR/ Project, centralize CA support for MY manufacturing/ Global Hub/ Ambu A/S. Ensure good documentation and change control as per QMS requirements. Be the Change Analyst to review and route change order in Agile system and ensure documents are reviewed and approved according to QMS requirements. Collaborate across Ambu sites and work closely together with R&D project teams to ensure approval of all related design and development documentation is in accordance with project plans. Supporting Ambu employees in understanding the requirements of change control process including conduct training in Agile. Requirements Degree in Science or equivalent. Preferably with min. 2 years work experience in related field. Knowledge in ISO 13485 & FDA regulations is an advantage. Innovative, committed with good accountability. Show more Show less

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