Ira Sharma Sankhayan Email & Phone Number

I have been working within the Med-tech and electronic industry since 2006. Presently working as a CEO at Yallow Life science. Job includes sales, marketing, HR and finances.Previous to that CCO, Leading a team with QA RA experts. Working as a PRRC role for many medical device companies. Working with products from class 1 to class III for quality, regulatory and design & development. Expertise in ISO 13485, ISO 9001, ISO 14001 and ISO 19011. Trainer for ISO standards.Worked as a Head of Quality and Regulatory at Otivio from 2018 to 2021. I got the new product CE marked and company certified ISO 13485 2016 certificate in the 1st 10 months of my job. Completed the CE marking, 13485 certification, QMS, 510K, MDR implementation, Manufacturing, logistics, Engineering, and supplier Quality. Lead Team for Design and development. Expert in ISO 13485, MDD, MDR and auditing. Have audited approx. 150+ companies with the scope including ISO 9001, ISO 14001, ISO 13485 and process audits.Worked in GEHealthcare as a commodity Supplier quality lead engineer handling the Nordic and European Electronic, HLA, plastic suppliers with head office in BUC Paris for 7 years. This position included managing supply chain suppliers, fulfilment, sourcing, engineering, returns, complaints, QA, Audits- internal, supplier an external. Have been a core team member for the major NPIs for medical class I, II a and b and class III devices. Has been a Lead Auditor doing internal audits, inter-site GEHC audits, supplier audits. The Supplier Quality work also included working with Biggest Suppliers in China, India, US too. Training master for ESD ( head for ESD in the centre of excellence team in GEHC) . I had been a part of standardizing the production processes, Change board processes and product related process at the GE Horten site. Have been awarded for my work as a simplification leader for the EMEA SQEs in 2015 leading to simplification of a lot of production related processes, project management tasks and procedures. Vernombud for the site. Certified in HMS, Foundation and building of leadership, Lean Six Sigma and project Management.After the master’s degree in Microelectronics, I worked with the Company Norautron. The products which i worked with for testing, repairing printed circuit boards, repairing test equipment were for Kongsberg Maritime, Tomra, British company for projectors. 5 yrs worked in every deptt of the company, including documentation, Chinese sister company of Norautron, Test department and project management.

Listed skills include Testing, Electronics, Quality System, Continuous Improvement, and 45 others.

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  University Of Oslo (Uio)

  Microelectronics