Senior Quality Assurance Engineer_Biomedical Product

13 hours ago

Dayuan District Taoyuan City, Taiwan GlycoGenetics, Inc. Full time $90,000 - $120,000 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 in Biomedical Product, located in the Dayuan District, Taoyuan City, Taiwan. This Senior Quality Assurance Engineer will be responsible for assisting our quality management representative in overseeing the overall quality assurance process of our protein-based IVD product line in compliance of the ISO13485 standard. 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 QMS is highly preferred. Prior working experience in regulatory affairs is also a strong plus.

Qualifications

  • Experience in Quality Management System for biomedical products
  • Deep knowledge in ISO standards or clinical regulations regarding quality assurance
  • Ability to work collaboratively in a team environment
  • Excellent analytical and problem-solving skills
  • Strong attention to detail and organizational skills
  • Knowledge in biochemistry or related fields

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