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• Ali R. Hobeheidar

Personal information

• Wants

  FDA Regulatory projects, EU Regulatory Projects, Contract manufacturing in plastic injection molding, Quality System consulting projects. SIx Sigma (DFSS - DMAIC)

• Haves

  Six-Sigma (DFSS / DMAIC) Quality Systems: EN46001, ISO13485, QS9000/TS16949, TL9000, and ISO9000: 2001. Device Consulting. FDA Regulatory. USA Representations EU Regulatory. EU Representations. Regulatory support in USA and EU Regulatory (e.g., developing regulatory strategies, time line development and reviewing submission related documents), Review and approval of product labeling for regulatory compliance and support required for CE marking activities, including preparation and maintenance of product technical files, Preparing and auditing 510(k) s, IDEs, PMA and/or international submissions. Total quality management, strategic Quality/Production planning, and public relations. Product liability, reliability, maintainability and product safety. Statistical process control (SPC). Total quality management (TQM). Design of experiment (DOE). DFSS, APQP, PPAP and COQ reporting. Contract manufacturing in plastic injection molding, Global Locations (ASIA, Europe and USA).

• Interests

  FDA, EU Regulatory, Medical Device, Plastics.

• Organizations

  American Society for Quality Medical Device & Diagnostic Industry Modern Plastic Industry Automotive Design & Production Industry

• Groups

  

• Employment status

  Entrepreneur

Educational background

• Languages

  English, French, Farsi