Irene Lin

Experience

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  Cathay General Hospital

  Jan 1995 - Jan 2005

  Medical Laboratory Technologist

  - Experience of as a medical technologist for the medical center for 10 years including blood bank, stat lab of clinical biochemistry, clinical microscopy lab, clinical microorganism lab, clinical virology lab, cytology lab, lung function unit and electrocardiographic unit. During this period, I studied and familiarised with relevant technologies such as biochemical, haemological, immunological, molecular-biological, bacteriological, and virological technologies.- Having experiences of ISO 15189 certification, aseptic processing for cell & virus culture and media preparation, operating in a biosafety level III lab and routine steam sterilization, etc.- Gained the Excellence in Research Award for my research on Apolipoprotein ε2/3 Genotype and Type III Hyperlipoproteinemia among Taiwanese and an Excellent Poster Paper Award from Chinese Association for Clinical Biochemistry.- In recent years (~2017) I have studied NGS including sequencing by synthesis (Illumina, Ion Torrent, PacBio...), sequencing by ligation (SOLiD) and direct DNA/RNA analysis (Nanopore). Show less

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  Taiwan FDA

  Jan 2005 - Dec 2010

  Medical Device Reviewer

  - Reviewed more than 300 IVD Technical Files (TF) from ROCHE, ABBOTT, SIEMENS, BD, DIAMED GMBH, BIO-RAD, SYSMEX, etc. and made the certification recommendations.- Presenting the TF assessment reports of new IVD products to Medical Devices Advisory Committee of Taiwan FDA for the marketability decision.- Obtained Taiwan GMP (equivalent to ISO13485:2003) and GLP training, both including on-site audits, and reviewed more than 300 GMP audit reports of MD/IVD manufacturing companies and made the certification recommendations.- Responsible for the consultation and training programs of the regulatory and the technical documentation requirements for medical device registration. Show less

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  SGS TAIWAN LIMITED

  Mar 2013 - Aug 2016

  Lead Auditor

  RABQSA Lead Auditor (ISO13485:2003; ISO9001:2008)CCAA Lead Auditor (QMS)SGS Medical Device Certification ApproverSGS Lead Auditor (ISO13485:2016; ISO9001:2015; MDD; IVDD)SGS IVD TF reviewer and TF expert Medical Technologist

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  Taiyao Nanotechnology Co., Ltd

  Sept 2016 - Feb 2022

  QA/ RA Manager

  -Implementation and maintenance of the quality management system including SOPs establishment, documentation/ QC results review and approval, and all quality & regulatory issues.-Responsible for OEM qualification (on-site auditing), QC requirements setting and approval for OEM’s SOP for our product-Medical devices (N99 medical respirator) and PPE (N95/ N99 filtering half masks) registration for Taiwan market.