Role: Quality Engineer II (Medical Device)
Location: Santa Clara, CA
Duration: 12 Months (W2)
Shift: 8:30 AM - 5:30 PM
Responsibilities
- Ensure compliance with software development procedures and regulations
- Review and approve deliverables, lead Hazard Analysis
- Assist in developing SOPs and training, write/test protocols
Impact
- Implement process controls and CAPA systems
- Lead quality improvement initiatives and investigations
- Support product verification and validation
Requirements
- BS in Engineering or related field
- Knowledge of FDA, GMP, ISO standards
- Experience with Quality tools, Six Sigma, and Lean Manufacturing
- Strong communication, project management, and leadership skills
If you are interested and willing to apply! Please contact me at ahmed@intellectt.com or
+1-732-653-9472