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.
