Ira Sharma Sankhayan

Ira Sharma Sankhayan Email and Phone Number

CEO at Yallow Life Science @ Yallow Life Science
oslo, oslo, norway
Ira Sharma Sankhayan's Location
Oslo, Oslo, Norway, Norway
Ira Sharma Sankhayan's Contact Details

Ira Sharma Sankhayan work email

Ira Sharma Sankhayan personal email

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About Ira Sharma Sankhayan

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.

Ira Sharma Sankhayan's Current Company Details
Yallow Life Science

Yallow Life Science

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CEO at Yallow Life Science
oslo, oslo, norway
Website:
yallow.no
Employees:
7
Ira Sharma Sankhayan Work Experience Details
  • Yallow Life Science
    Chief Executive Officer
    Yallow Life Science Oct 2023 - Present
    Oslo, Oslo, Norway
    Yallow is an ISO 13485 certified design & development partner specialized in medical and health technology. We are passionate about developing products and services that really mean something and make a difference. Together with our clients, we improve the future.We are dedicated and purpose driven specialists and a trusted partner in medical and health innovation. We provide services within design & development and quality & regulatory support. Yallow is a unique fusion of a design and regulatory agency. Let’s innovate better life! We identify ourselves us explorers and ground breakers who share a rather simple but meaningful WHY: For better life.Yallow is a part of VINN Group, which consists of 15 other companies in Sweden. Yallow represents Vinn group in Norway.
  • Yallow Life Science
    Chief Compliance Officer
    Yallow Life Science May 2021 - Oct 2023
    Norway
    QA RA Consultant, Lead auditor ISO 13485, ISO 9001, ISO 14001. Trainer - ISO 13485, ISO 14971, ISO 9001, ISO 14001.Trainer -Supplier Management.Audited more than 20 + companies in this role- Supplier audit and internal auditsRegulatory navigation MDR technical file, QMS implementation, eQMS implementation, Class 1, IIa, IIb and III. Distributor and importer requirement expert. Team Leader - QA RA Management Representative.PRRC role and advisor for many med. tech companies.
  • Otivio As
    Head Of Quality And Regulatory Assurance
    Otivio As Mar 2018 - May 2021
    Oslo, Oslo, Norway
  • Otivio As
    Qa Ra Manager
    Otivio As Mar 2018 - Apr 2019
    Oslo, Oslo, Norway
  • Ge Healthcare
    Supplier Quality Lead Engineer
    Ge Healthcare Aug 2014 - May 2021
    Norway
    I have responsibility for the quality of products coming from one of the biggest electronics and HLA suppliers in Nordic countries. These suppliers are the suppliers to GEHC, not just for Norway but whole EMEA, Japan, US and other parts of the world.I do supplier audits for the Norway site and other EMEA site requests- based ISO 9001 and ISO13485 yearly. Average audits done are from 5 to 7 supplier per year. Simplification leader for EMEA supplier Quality team 2015. Center of excellence team member and leader for ESD and other HLA related projects. NPI Core team member and leader for supplier quality and purchasing roles.
  • Ge Healthcare
    Supplier Quality Engineer
    Ge Healthcare Jan 2011 - Aug 2014
    Norway
  • Norautron As
    Test Engineer / Project Handling (R And D)
    Norautron As Jan 2005 - Dec 2010
    Norway, Horten
    I started working as test engineer expert, repairing boards, testing multiple level boards, projectors and maintaining test jigs.Later took over the responsibility for correcting and implementing documentation for testing and work instructions. Worked as a project leader in the last year, helping in the transition of ERP systems, order handling and customer care.

Ira Sharma Sankhayan Skills

Testing Electronics Quality System Continuous Improvement Manufacturing Quality Management Supplier Quality Project Management Medical Devices Six Sigma Cross Functional Team Leadership Product Development Lean Manufacturing Supply Chain Management Process Improvement R Quality Assurance Iso 13485 Management Iso Standards Quality Auditing Engineering Research And Development Leadership Failure Mode And Effects Analysis Root Cause Analysis Team Leadership Dmaic Microsoft Office Statistical Process Control Iso 9001 Program Management Engineering Management U.s. Food And Drug Administration Microsoft Excel Validation Quality Control Sourcing 5s Project Planning Product Management Training Design Control Customer Service Design For Manufacturing Corrective And Preventive Action Product Quality Supplier Audits Regulatory Affairs

Ira Sharma Sankhayan Education Details

Frequently Asked Questions about Ira Sharma Sankhayan

What company does Ira Sharma Sankhayan work for?

Ira Sharma Sankhayan works for Yallow Life Science

What is Ira Sharma Sankhayan's role at the current company?

Ira Sharma Sankhayan's current role is CEO at Yallow Life Science.

What is Ira Sharma Sankhayan's email address?

Ira Sharma Sankhayan's email address is ir****@****ahoo.no

What schools did Ira Sharma Sankhayan attend?

Ira Sharma Sankhayan attended University Of Oslo (Uio).

What are some of Ira Sharma Sankhayan's interests?

Ira Sharma Sankhayan has interest in Social Services, Children, Economic Empowerment, Environment, Education, Poverty Alleviation, Science And Technology, Disaster And Humanitarian Relief, Human Rights, Animal Welfare.

What skills is Ira Sharma Sankhayan known for?

Ira Sharma Sankhayan has skills like Testing, Electronics, Quality System, Continuous Improvement, Manufacturing, Quality Management, Supplier Quality, Project Management, Medical Devices, Six Sigma, Cross Functional Team Leadership, Product Development.

Who are Ira Sharma Sankhayan's colleagues?

Ira Sharma Sankhayan's colleagues are Eirik Smolan, Mohammad Albatat, Amrita Kaur, Abdul Vajid, Mikkel Lager.

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