Quality Engineer - Irvine, CA, CA | Biospace
Get Our FREE Industry eNewsletter

Quality Engineer

Apex Life Sciences

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

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.  


•   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