Quality Engineer (NOT software quality):
Required Skills &
Experience
3-5 years experience in Quality Engineering in a regulated environment (either biotech, aerospace, automotive, pharma) can be ISO or FDA regulated
Fluent in both English and Spanish
Experience with nonconformances (NCRs)
Experience with FMEA/process FMEA
Job Description:
The Quality Engineer supports the development and improvement of products and processes by applying associated quality methods. Working on cross functional teams in a regulated environment to ensure quality, safety, reliability, and efficacy of products and processes. Aiding the company in becoming ISO certified will also be a huge focus of the role. The ideal candidate will have worked in an ISO-regulated, FDA compliant industry in their recent roles.
Key Responsibilities:
Help to Mitigate and Eliminate Quality Fade as changes are implemented
Daily Review, Revise, and Create Documents such as SQS, SQRs,and Work Instructions
Contribute and collaborate with SCAR, NCMRs, and ICAR investigations
Train and mentor QC personnel
Collaborating with Engineering and Manufacturing in Product Development Quality Matrices
Support IQ, OQ, PQ activities on new and existing products
Create and Manage Manufacturing and Quality KPI Data and Trends
Contribute to Risk Assessment and Analysis
Compensation
$40.00/hour to $52.00/hour