Company: Oxenham Group LLC
Location: Salt Lake City
Posted on: November 26, 2022
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
- 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
- Master Validation & Verification Plan for each finished good
- 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
- 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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