Background

My name is Shelly Tomson and I have been in Quality for 25+ years. I am very versed with ISO 13485:2016 and FDA QSR 820. I am currently seeking employment in a Medical Device Company or a challenging job that could use my experience.

Job experience

• September 2017 - March 2020
  Quality Specialist II
  Second Sight Medical Products
  

  San Fernando, CA, USA

  • Internal Lead Auditor
  • Assist Document Control process
  • Assist with External Audits
  • Maintain all Quality System Records
  • Assist with training records, requirements and documents
  • Assist Quality Engineer in the collection and monitoring of quality data
  • Assist with QAD Inventory Maintenance and Reliance updates and releases
  • Safety Team and Employee Activity Committee member
  • Training Coordinator
  

• July 2013 - September 2017
  Document Control and Internal Auditor Lead
  Beckman Coulter
  

  Chatsworth, CA USA

  • Document Control Specialist
  • Internal Auditor Lead
  • External Standard Coordinator
  • Oracle Professional Lead and Administrator
  • Regulatory Affairs Associate/Specialist
  • Incorporated labeling process to GS1, GTIN, GHS, UDI
  • Maintained GLPs, GMPs and GDP’s at all times
  • Safety Team and Employee Activity Committee member
  • Training Coordinator Lead
  

• May 1996 - July 2013
  Document Control Lead, Internal Audit Lead and Regulatory Support Specialist
  Iris Diagnostics
  

  Chatsworth CA USA

  • Lead Administrator to the Director of Regulatory and Quality Affairs
  • Internal Auditor Lead, Supplier Auditor and Subsidiary Auditor (Full Scope Audits)
  • Lead of internal documentation process, data management and record updates release and change control processes
  • Lead Federal, State and International documentation requirements and required disclosures
  • Lead ERP/MRP System and database
  • Lead Corrective and Preventive Action Process
  • Updated and wrote SOP’s, DOP’s and Work Instructions
  • Ensured accuracy and integrity of Document Control, Data Control and Record Retention process
  • Lead Document Control Clerk(s) to ensure timely and accurate workflow
  • Lead labeling projects
  • Safety Team and Employee Activity Committee member
  

Education

• Canyon High School
  Diploma
  

  - present

  High School
  Some college at College of the Canyons. Still attending school at COC.

• Many
  ISO
  None
  

  May 1996 - September 2018

  • Oriel Stat-A-Matrix Lead Auditor Training Course ISO 13485:2016 Certification – September -2018
  • Oriel Stat-A-Matrix Medical Device Single Audit (MDSAP) Program Training - March - 2018
  • Danaher Shingijutsu Kaizen – April – 2016
  • Medpoint Internal Audit Workshop ISO 13485:2003 and 21 CFR 820 – February -2016
  • RAC Certification for Medical Devices – (Itinerary Below) January – 2014
  o History of Medical Devices in EU
  o The Medical Device Directive
  o The IVDD, AIMDD plus other Directives and Guidance Documents
  o Standards, Quality Assurance and Risk Management
  o Post Marketing Requirements
  • BSI ISO 13485:2003 and QSR Internal Quality Systems – July – 2011
  • ASQ Certified Quality Auditor Training Course – June – 2009
  • RABQSA Auditor/Lead Auditor Training Certification – March – 2009
  • Document Control and Records Management Course – March – 2007
  • RAP’s Overview of Medical Devices – June – 2006
  • ASQ Implementing ISO 13485:2003 April – 2005
  • Auditing (FDA, Notified Body and Internal Audits) Course – November – 2005
  • ISO 13485:2003 for Canadian Medical Device Regulation – July – 2004
  • Department of Commence for Export Administrator – 2001 -2002 – 2003 -2008
  • CEO Leadership - August – 2001
  • Solidworks Administrator 3-D Cadware – September - 2001