Quality Engineer (Irvine)
Stellar Consulting Solutions, LLC, Irvine, CA, United States
Role: Quality Engineer
Location: Irvine, CA, Onsite
Job Type: Contract
About the Role
We are looking for a
Quality Engineer
to support product and process quality activities, including validation, complaint investigations, and regulatory compliance. This role involves working closely with cross-functional teams to ensure products meet quality and regulatory standards.
Key Responsibilities
Support process, equipment, and method validation activities
Write and execute test protocols and validation reports
Assist in complaint investigations, CAPA, and non-conformance handling
Perform root cause analysis and support corrective actions
Work with cross-functional teams on production and process improvements
Apply basic statistical analysis and quality metrics
Ensure compliance with FDA / ISO / cGMP standards
Required Skills & Experience
2–5 years of experience in Quality Engineering / Quality Assurance
Hands-on exposure to validation (process/equipment/test methods)
Experience with complaint handling, CAPA, or non-conformance
Basic understanding of FDA, ISO (preferably ISO 13485), or cGMP
Strong documentation and communication skills
Experience in regulated manufacturing environment preferred
Nice to Have
Exposure to statistical tools / SPC
Experience in medical devices or pharma industry
Location: Irvine, CA, Onsite
Job Type: Contract
About the Role
We are looking for a
Quality Engineer
to support product and process quality activities, including validation, complaint investigations, and regulatory compliance. This role involves working closely with cross-functional teams to ensure products meet quality and regulatory standards.
Key Responsibilities
Support process, equipment, and method validation activities
Write and execute test protocols and validation reports
Assist in complaint investigations, CAPA, and non-conformance handling
Perform root cause analysis and support corrective actions
Work with cross-functional teams on production and process improvements
Apply basic statistical analysis and quality metrics
Ensure compliance with FDA / ISO / cGMP standards
Required Skills & Experience
2–5 years of experience in Quality Engineering / Quality Assurance
Hands-on exposure to validation (process/equipment/test methods)
Experience with complaint handling, CAPA, or non-conformance
Basic understanding of FDA, ISO (preferably ISO 13485), or cGMP
Strong documentation and communication skills
Experience in regulated manufacturing environment preferred
Nice to Have
Exposure to statistical tools / SPC
Experience in medical devices or pharma industry