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Quality Engineer

Company: Oxenham Group LLC
Location: Salt Lake City
Posted on: November 26, 2022

Job Description:

The Oxenham Group just won a bid with a Medical Device CDMO who is looking to bring production of their catheters from California to Utah. They are looking to bring on 3 Quality Professionals (1 Lead and 2 Engineers).

Scope of Work:

  • Assessment of current OEM manufacturing equipment, process, packaging, sterilization, Pre-Production QA (prints, specs, BOM, V&V, etc.), outgoing QC, training materials, visual aids, and other Quality/Manufacturing documentation.
  • Gap Assessment Report and identification of all required Action Items
  • Review of our client's inventory of equipment, jigs, fixtures, and infrastructure that either must be purchased, fabricated by the client, or fabricated by company.
  • Develop Sterilized Product Release, Return, Quarantine, Test and Re-release Process
  • Risk Assessment development (e.g., PFMEA)
  • Oversight of Supply Chain support and transfer to company (incl. company Spec creation, AVL, specs, manage suppliers)
  • Master Validation & Verification Plan for each finished good sku
  • Creation of Protocols and Reports for each in-process assembly step and final Testbed (IQ/OQ/PQ)
  • Effect the transfer of SOPs, training materials, and other documentation into Company's Quality System
  • Quality support of the new production line assembly at Company SLC including QC/Quarantine/Rework stations
  • Training materials development and operator/technician training
  • Quality Control setup, documentation, and training including TMV/Gauge R&R for all Incoming Inspection Equipment

Keywords: Oxenham Group LLC, Salt Lake City , Quality Engineer, Engineering , Salt Lake City, Utah

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