Helen Salimi-Tari

Experience

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  Biomerica

  Feb 2005 - Apr 2007

  Quality Control Manager
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  Osmetech Molecular Diagnostics

  Mar 2008 - Dec 2008

  Quality Specialist

  Quality Control Manager at Biomerica.

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  Arbor Surgical

  Jun 2009 - Oct 2010

  Documentation Specialist/QA
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  Bausch + Lomb

  Jun 2010 - Aug 2010

  Complaint Specialist

  Reviewed complaint files from all domestic and international clients. Followed regulatory requirements both domestic and internationally (FDA, ISO, MEDDEV etc.).

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  Endologix Inc

  Sept 2015 - now

  Complaint Coordinator
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  Johnson & Johnson

  Jul 2016 - now

  Senior Complaint Specialist ( Medical Device Reporting)

  • Perform and evaluate all information from a clinical and technical perspective to ensure appropriate Subject codes, Analysis, Investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure. • Ensure proper documentation and closure of each complaint in order to make and document sound regulatory reporting decisions/justifications for worldwide reporting.• Develop, establish, prepare and distribute dashboards and reports to ensure complaints are processed and coded in a timely manner. • Develop a thorough understanding of the complaint database. • Develop, prepare, and analyze reports for coded complaints on a weekly and monthly basis, as required. • Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, CMDCAS, PMDA and other worldwide regulatory agencies.• Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance. Show less