What are the responsibilities and job description for the Quality Engineer II (Medical Device) position at TekOne IT Services Pvt. Ltd.?
Role: Quality Engineer II (Medical Device)
Location: Santa Clara, CA
Duration: 12 Months (W2)
Shift: 8:30 AM - 5:30 PM
Responsibilities
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
- Implement process controls and CAPA systems
- Lead quality improvement initiatives and investigations
- Support product verification and validation
- 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
