Quality Engineer (Irvine)
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
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