Quality Engineer - Irvine, CA, CA | Biospace
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Quality Engineer

Apex Life Sciences

Location:
Irvine, CA, CA
Posted Date:
9/12/2017
Position Type:
Contract, Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Engineering, Manufacturing, Manufacturing/Production, Medical Device, Pharmaceutical, Quality,

Job Description

JOB DESCRIPTION
The Quality Engineer is responsible for supporting remediation of test method validation and execute test method validations, develop inspection procedures and complete test reports.
•   Optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.  Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
•   Develop, update, and maintain technical content of risk management files
•   Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
•   Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
•   Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.  

Requirements

JOB REQUIREMENTS
•   4-6 years of relevant work experience in a FDA regulated industry (medical device, biotech, or pharmaceutical)
•   Bachelor's degree in Engineering required (biomedical or mechanical preferred)
•   Certified Quality Engineer (CQE) and Six Sigma certification is a plus