Senior Quality Assurance Engineer_medical devices

13 hours ago

Dayuan District Taoyuan City, Taiwan GlycoGenetics, Inc. Full time NT$900,000 - NT$1,200,000 per year

Company Description

GlycoGenetics, Inc. is a glycobiology-centric biotechnology company based in Taiwan. Our R&D efforts focus on developing integrated biochemical, cellular, and genetic platforms to understand the complex glycocodes of human biology. We aim to apply glycobiology to address unmet medical needs, offering glycan-detecting
reagents for basic research and clinical diagnosis. Our long-term goal is to address unmet medical needs through new biomarker and therapeutic target discovery.

Role Description

  • This is a full-time, on-site role for a Senior Quality Assurance Engineer, located in the Dayuan District, Taoyuan City, Taiwan. The candidate will be responsible for assisting our quality management representative in overseeing the overall quality assurance process of our RUO
    and IVD reagents
    in compliance to the ISO13485 and related quality standards. The role involves managing the quality management system along with our RA team, working with our R&D team to establish product quality standards, and working with the QC team to ensure the quality and stability of our products through rigorous testing protocols. The candidate is expected to have at lease 3 years of working experiences in quality assurance or quality control, especially in the biomedical sectors. Experience in ISO13485, ISO14791 and related quality management systems is highly preferred.

Qualifications

  • Experience in ISO13485 or related Quality Management Systems
  • Ability to work collaboratively in a team environment
  • Technical skills and knowledge d in analytical biochemistry methodologies
  • Excellent analytical and problem-solving skills
  • Strong attention to detail and organizational skills
  • Sufficient knowledge in biochemistry or related scientific fields

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