Quality Engineer I
Select Source International · Pleasanton, CA · 1 wk ago
On-siteQuality AssuranceContract
Key Responsibilities
- Support validation activities
- Aid in equipment, process, and software validation (including CSV)
- Document quality issues
- Create, review, and maintain quality control documents, reports, and production records
- Conduct CAPA investigations
- Assist with nonconformance management
- Evaluate product defects, deviations, and MRB activities
- Perform data analysis
- Support audits and inspections
Requirements
- Support the design, manufacturing, and maintenance of safe, compliant medical devices
- Support validation activities
- Document quality issues
- Prepare, review, and maintain quality control documents, reports, and production records
- Conduct CAPA investigations
- Assist with nonconformance management
- Evaluate product defects, deviations, and MRB activities
- Perform data analysis
- Support audits and inspections
Qualifications
- Bachelor's degree in Engineering, Biomedical Engineering, Quality Engineering, or related field
- Understanding of FDA QSR, ISO 13485, and basic risk management principles
- Strong attention to detail, integrity, and accountability in documentation and compliance
- Ability to interpret technical drawings, procedures, and test methods
- Proficiency with MS Office and basic statistical tools