Sr. Medical Device Quality Engineer

Los Angeles, CA

Job ID: 127467 Industry: Med

Sr. Medical Device Quality Engineer

Our client is a service company that refurbishes Ultrasound Systems to the healthcare industry. Their process ensures that each technically and cosmetically reconditioned ultrasound system looks and performs like new.

Project Scope &  Responsibilities:

Our client is looking for a Sr. Quality Engineer to support new equipment initiatives. They recently bought refurbished million dollar equipment that need to be validated. This individual will be setting up the process, validate the equipment, write protocols, process controls, and work with the Quality team from an operational standpoint. They will be responsible for establishing and directing the project team regarding Quality requirements; to provide the most efficient end to end project implementation from part concept through first production order including assembly transfer, if applicable. This individual will direct quality assurance activities for all current and future medical/commercial products. They will enact and manage Quality elements of transfer to manufacturing to include formal documentation and implementation of process flow, risk analysis (pfmea), control plans, inspection plans, measurement fixtures, and measurement equipment. They will be responsible for master Validation activities, including IQ, OQ, PQ; measurement system analysis, gage R&R, and measurement correlation Manage and perform activities associated with CAPA, Complaints, Non-Conforming Materials, Inspection and Calibration. They are looking for someone with at least 5-7 years’ experience in the medical device industry that can be hands on.

  • Medical Device Experience
  • Quality
  • Equipment Validation

  • Ultrasound Systems

Job Type: Contract

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