Linda is a Standard Development Manager with the National Standards Authority of Ireland (NSAI) and manages a number of national standard committees in the Healthcare and lifescience area.
This involves monitoring international standard developments in many areas including medical devices safety, biotechnology, health informatics and genomics.
Topics covered under medical device safety includes;
• biocompatibility,
• sterilization,
• quality and risk management,
• clinical safety, labelling and many more.
Linda works with national stakeholders to provide feedback on behalf of Ireland on the development of International standards.
Prior to working in standard development Linda worked as an auditor with NSAI certification and Notified Body, involved in quality management system audits and reviewing technical files as part of the CE Mark approval process.
Prior to joining NSAI Linda also worked in the medical device industry as a Quality and Regulatory Affairs Manager.
Liz is Principal Quality Engineer in the Sterility Assurance team at the Galway Parkmore Medtronic facility. Liz has over 30 years of industry experience in the pharmaceutical and medical device industries. Liz has experience with EO, E-Beam, Gamma, Moist Heat and Dry Heat sterilization modalities as well as Microbiology Lab. management. Liz received her B.Sc. degree in Microbiology and M.Sc in Biotechnology from the University College Galway. She is a Certified Industrial Sterilization Specialist to the AAMI Credentials Institute and holds accreditation for CISS-Ethylene Oxide and CISS-Radiation.
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Dr Ann O’Connell PhD is a visionary leader, a dynamic collaborator. As Head of Funded projects for Medtech and Engineering Skills with Ibec, Ann is responsible for funding, development and delivery of over 100 professional upskilling programmes ranging from 1-day webinars, to 2-year Masters programmes. Ann’s course list is wide ranging and comprehensive, covering Research & Development, Manufacturing & Digitalisation, Quality & Regulatory, Sustainability, and Management & Leadership, and she specialises in piloting and launching new programmes to meet emerging needs.
Ann completed her PhD in 2014 with the Centre for BioNano Interactions (CBNI) at University College Dublin and is a longtime advocate for lifelong learning amongst industry professionals. She joined Ibec in 2019 from Irish Manufacturing Research Centre, where as the European Programme Manager, she refocused strategy and investment and led the successful application of a proposal to coordinate a H2020 funded project under the ECSEL JU Program. Prior to that, Ann served as Senior Integration Engineer with Intel Corporation for almost two decades, supporting multiple business sectors across diverse geographies, Ann’s deep understanding of the power of technology, digitalisation, data science and intelligent automation in advancing all businesses is applied with expertise and purpose in her role today, as she supports the industries that will solve some of the world’s most critical health and environmental challenges.
Gerry is Senior Principal Quality Engineer in the Sterility Assurance team at the Galway Parkmore Medtronic facility. Gerry has over 25 years of industry experience in the pharmaceutical and medical device industries; 7 years of which has been at Medtronic. Gerry received his B.A. degree in Microbiology from the University College Galway. He is a Certified Industrial Sterilization Specialist to the AAMI Credentials Institute and holds accreditation for CISS-Ethylene Oxide.
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