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Director of Quality

Fremont, CA 94538

Employment Type: Direct Category: Quality Manager Job Number: 9722 Pay Rate: $160,000.00 - $175,000

Job Description

  • Bachelor’s Degree in Mechanical, Manufacturing, or Industrial Engineering preferred
  • Ideal candidate will have 8+ years of industry experience in quality or regulatory role. At least 4 years of experience in the medical device industry
  • Certified Quality Auditor
  • Previous experience hosting FDA, ISO 13485, ISO 9001, and clean room audits
  • Experience with Design History Reviews, Lot Reviews, etc.
  • Experience with sending products out for sterilization with ETO and if possible also other methods such as X-ray and  E-Beam
  • Strong communication and negotiation skills
  • Manage and update QMS according to customer requirements and maintain compliance with ISO 13495, 21CFR820
  • Serve as regulatory expert to existing and prospective clients; demonstrate expertise in medical standards, manufacturing, and compliance with regulatory bodies
  • Manage suppliers to ensure compliance standards are met
  • Collaborate with internal team and vendors on solutions to timeline issues and changes in customer requests
  • Serve as representative for quality audits and inspection by competent authorities, notified/regulatory bodies, customers, and other third parties. Audits include manufacturing lines and clean rooms.
  • Consult clients on how manufacturing can be done efficiently and compliance with quality standards
  • Create reports on performance of quality system and advise on improvements to be made

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