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 :
$32-$39 / HR to start!
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.
Qualifications :
Bachelor’s degree in engineering field is required.
Experience in a regulated industry is required (FDA or medical device environment is preferred).
Must have some experience with root cause analysis, CAPAs, investigations, or nonconformities (complaint investigations is a plus!).
Must be proficient in MS Office.
Knowledge of FDA regulations, 21 CFR part 820 and Part 803, ISO 13485, and ISO 14971 standards is preferred.
If you are interested in hearing more about the position, please respond to this posting with your resume attached or contact me at (phone number removed).
Please forward this email to any friends or colleagues as we do offer a Referral Bonus for any candidate who is hired and still gainfully employed after 30 days.
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