James Coburn

Experience

• 

  Pemstar Ireland Ltd

  Jan 2000 - Jan 2007

  Quality / I.T. Manager

  Responsible for the administration of the QMS with authority to manage all work affecting quality. Directed all aspects of the I.T. infrastructure and budgetary requirements. The elements of the role included the following :-ISO Certification (EMEA) Transferred and integrated the QMS procedures and supervised the successful registration audits for ISO 13485 medical devices in the EMEA region including sites in Holland, Romania and Israel.-FDA Registration Chaired the FDA establishment registration and device listing protocols for the EMEA region including sites in Holland, Romania and Israel.-3rd Party Audit Host Front room team leader for all 3rd party audits including CE marking, known consignor and surveillance audits.-ISO Certification (Ireland) Successfully implemented ISO quality management systems on a greenfield site in Navan, Ireland leading to medical device certification. Show less

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  Benchmark Electronics

  Jan 2007 - Jan 2012

  Quality / I.T. Manager

  Responsible for the leadership and support of regulatory affairs in the European Business Centre. Charged with the unification of QMS methodology and certifications across sites. -Lead Auditor (Bus. Dev.) First choice candidate for leading site preparations for business-critical customer audits – in 2011 – chaired qualification audits for $30 million business wins in Europe and the U.S.A.-FDA Registration Co-ordinate and upgrade internal regulatory processes such as internal audits, inspections, licence renewals or registration.-Product Launch Process Review and implemente product promotional materials, labelling, batch records, specifications sheets and test methods for compliance with applicable regulations and policies.-I. T. Initiatives Experience managing full I.T. project lifecycle from requirements gathering to final implementation – VoIP implementation cut telephony costs by 150% in EBC. Show less

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  InnaLabs® Ltd

  Jan 2012 - now

  Accountable for the administrative, financial, and risk management operations of the company, to include the development of a financial and operational strategy, metrics tied to that strategy, and the ongoing development and monitoring of control systems designed to preserve company assets and report accurate financial results Responsible for making sure InnaLabs operates and complies with statutory and legal provisions. Chair all meetings with company shareholders and the board of directors and act as a point of communication between them. Also responsible for ensuring that the highest standards of administrative processes & corporate governance are both promoted and maintained Management and coordination of quality control teams while making sure products meet safety and quality standards by ensuring that the processes needed for the Quality Management System (QMS) are established, implemented and maintained.Oversee and report on the performance of the QMS, while also promoting the awareness of customer requirements throughout the organisation and liaising with external assessment bodies on all matters related to the QMS accreditation process.

  • Chief Financial Officer

    Jan 2016 - now

  • Company Secretary

    Jan 2014 - now

  • Vice President Of Quality

    Jan 2012 - now