Ira joined Otivio in March 2108 and is presently Head of Quality and Regulatory Assurance. Her role has involved CE marking, 13485 cetification, Quality system management, 510K implementation, and preparing for the implementation of the EU Medical Device Regulations
She has previously worked for GEHC as a commodity Supplier quality lead engineer working handling the European Electronic team with head office in BUC Paris for 7 years, which included working with supply chain managing supplier quality and fulfillment issues.
Ira has also had roles such as being a core team member for the major NPIs for medical class 2 equipments and a Lead Auditor doing internal audits, intersite GEHC audits, supplier audits, and she has audited approximately 40 suppliers for ISO 9001 and ISO 13585 qualification.
Ira has several awards and certifications, for example, she was an awarded simplification leader for the EMEA SQEs in 2015 leading to simplification of a lot of production related processes, project management tasks and procedures. Certified in HMS, Foundation and building of leadership, Lean Six Sigma and project Management.
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