Medpoint » Nuclear Products http://www.medpoint.com Device, Pharmaceutical, Biotech Tue, 31 Jan 2012 21:44:28 +0000 en hourly 1 http://wordpress.org/?v=3.1 J.J.F. http://www.medpoint.com/jjf-massachusetts/ http://www.medpoint.com/jjf-massachusetts/#comments Thu, 30 Oct 2008 16:44:52 +0000 PECULIAR http://medpoint.timpecoraro.com/?p=199 Accomplished RAC professional with substantial regulatory, standards, quality and design assurance expertise.  Thirty years experience in the complex Medical Device and Nuclear Products industry.

Titles Held: Senior Manager of Design Assurance; Director of Design Assurance; Senior Manager of Design Quality Assurance; System Qualification Manager

  • Product Development lifecycle, product design compliance to the QSR and MDD, as well as best practices for speed and effectiveness
  • Skilled in all areas of Design Assurance such as product risk analysis including software, product design, process validation, process software validation, equipment commissioning and equipment servicing
  • Full understanding of ISO 13485, MDD, technical standards, conformance and regulations for EU, Japan and Australia
  • Senior Manager experienced with MDR’s and recall decision making as well as product safety
  • Face to face experience with FDA and ISO audits the as well as back room support including recovery from Warning Letters
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