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Quality Engineer II (Medical Device)

  • Full Time, onsite
  • TekOne IT Services Pvt. Ltd.
  • Santa Clara, United States of America
Salary undisclosed

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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 [email protected] or +1-732-653-9472