Quality Engineer
Katalyst CRO · Pleasanton, CA · 1 mo ago
On-siteQuality AssuranceContract
Roles & Responsibilities
- Support equipment, process, and software validation (CSV, IQ/OQ/PQ).
- Assist with CAPA, non-conformance (Client/MRB), and root cause investigations.
- Maintain quality documentation and analyze quality metrics.
- Support internal/external audits and ensure compliance with FDA, ISO 13485, and GMP requirements.
- Collaborate with Engineering, Manufacturing, and R&D on quality initiatives.
Requirements
- Bachelor's degree in Engineering, Biomedical Engineering, or a related field.
- 0-3 years of experience in Medical Devices, Pharma, Biotech, or other regulated manufacturing environments.
- Basic knowledge of FDA 21 CFR 820, ISO 13485, CAPA, Validation, and Quality Management Systems.
- Strong analytical, documentation, and communication skills.
- Exposure to CSV, IQ/OQ/PQ, ISO 14971, GMP, or cleanroom environments.