Quality Engineer
Job in
San Diego, San Diego County, California, 92101, USA
Listed on 2026-07-01
Listing for:
E-Solutions
Full Time
position Listed on 2026-07-01
Job specializations:
-
Engineering
Quality Engineering, Regulatory Compliance Specialist, Biomedical Engineer, Pharma Engineer -
Quality Assurance - QA/QC
Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Quality Engineer
Validation and Quality Engineer with 3+ years of experience supporting FDA and ISO 13485 regulated medical devices across manufacturing, validation, design transfer, and QMS harmonization activities. Strong expertise in IQ/OQ/PQ, Verification & Validation (V&V), Test Method Validation, and risk management, with audit ready documentation experience.
Key Responsibilities:
- Execute and document process and equipment validations (IQ/OQ/PQ)
- Develop and author GMP compliant validation protocols and reports
- Support V&V, TMV, and requirements traceability per Design Controls (21 CFR 820.
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