品保資深工程師_生醫試劑

哥吉生技致力於開發醣生物學之試劑以用於基礎生科研究與臨床檢測醫材。公司正在尋找具有生醫領域產品開發經驗或品質管理經驗之品保專家，協助建立與管理符合ISO13485之品質管理系統，工作項目包括: 1. 建立與維持品質管理系統，主導品質活動之推行。 2. 與研發團隊合作，訂定品質標準， 協助產品製程相關品質管理與異常處理。 3. 主導內部稽核作業，與品管團隊合作，落實品質水準，確保品質管理系統的有效性。 4. 主導風險管理計畫，協調各部門組成風險管理小組進行風險管理活動。 5. 與法規部門合作，達成品質相關法規與認證合規。 6. 執行內部教育訓練，強化員工對品質系統的認知與遵循。 7. 參與核心決策活動以維持公司品質水準。 資格條件： 合格之應徵者需具有極佳的溝通聆聽與充足的團隊合作經驗，並能靈活運用量化分析。生醫、化學相關科系畢業或有充足的生物化學相關領域工作經驗，並有三年以上於品保品管相關工作經驗。具備建立ISO13485品質管理系統、ISO14971風險管理經驗尤佳。 --- 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 protein-based 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. This Senior Quality Assurance Engineer will be responsible for assisting our quality management representative in overseeing the overall quality assurance for our protein-based products in compliance to the ISO13485 standard. The role involves managing the QMS and overseeing the quality assurance activities, working with our RA team to meet QMS-related regulatory requirements, 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 procedures. Qualifications 1. Minimal 3 years of experience in quality-related roles in biotechnology or related industries 2. Experience in ISO quality standard compliance is a strong plus 3. Ability to work collaboratively in a team environment 4. Excellent communication skills to bridge teams of different functions 5. Skills in quantitative analysis 6. Sufficient knowledge in biochemistry or analytical chemistry