Quality Engineer
Katalyst CRO · Santa Clarita, CA · 1 mo ago
On-siteQuality AssuranceContract
Responsibilities
- Review and support design verification protocols, reports, and summary documentation.
- Evaluate test method validations, test fixture qualifications, and regression analysis.
- Support risk management activities, including dFMEA reviews and impact assessments.
- Review build protocols, DHRs, configuration changes, and design control deliverables.
- Support installation qualification (IQ) activities for software and test equipment.
- Collaborate with cross-functional teams on defect tracking, test execution, and quality improvements.
- Review mechanical/electrical design changes and inspection plans for components and sub-assemblies.
Requirements
- Medical Device Quality Engineering.
- Design Verification & Validation (DV&V).
- Design Controls.
- Risk Management (dFMEA).
- Test Method Validation.
- DHR Review & Documentation.
- New Product Development (NPD).
- Regulatory Compliance & Quality Systems.
Preferred Skills
- FDA/ISO 13485 Medical Device Regulations.
- Product Development Lifecycle.
- Cross-Functional Quality Support.
Experience
- 4-6 Years in Medical Device Quality Engineering or Product Development Quality.