Quality Engineer

6 days ago


Irvine, United States The Fountain Group Full time

The Fountain Group is currently seeking a ­­­­­­Quality Engineer for a prominent client of ours. This position is located in ­­Irvine, CA. Details for the position are as follows:

Job Description:

  • $30-$36/HR
  • 12-month assignment (with potential to extend or convert based on performance and budget).
  • Main responsibilities include:
  • Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
  • Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
  • Monitors and analyses product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
  • Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
  • Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
  • Proficient in project management, data analysis, root cause analysis, communication, and risk determination
  • Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.
  • 100% Onsite

Qualifications:

  • Bachelors degree in Engineering is required (biomedical or mechanical is preferred).
  • Some professional experience is preferred (open to recent graduates with related academic experience).
  • Knowledge of root cause investigations/ analysis, CAPAs and non conformances
  • Quality exp within manufacturing investigations, product performance, and post-market performance of medical devices preferred
  • Exp with medical device complaints (MDR/ MDV) preferred
  • Exp with FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices preferred.
  • Knowledge of Six Sigma preferred.

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