Quality Assurance Engineer 2

Smith+Nephew

Kharadi, Pune, India
Not specified; not specified; major medical covera...
Hybrid
Design control requirements
Risk management documentation
Verification and validation test methods

Salary

Not specified; Not specified; Major medical coverage; Educational Assistance; Flexible Personal/Vacation Time Off; Free Cab Transport; One-Time Meal provided

Skills & Requirements

Must-have

  • Design Control requirements
  • Risk Management documentation
  • Verification and validation test methods
  • FDA 510k and CE Mark approval
  • ISO 13485 and IEC 62304 standards

Nice-to-have

  • ASQ CQE or CRE certification
  • Jama or Cockpit requirement management
  • Python programming proficiency
  • Oscilloscopes and function generators
  • Cross-functional team collaboration

Key Requirements

  • B.S. in Electrical, Computer, or Biomedical Engineering
  • M.S. in Engineering preferred
  • 2+ years in medical device industry
  • Knowledge of GMP, QSR, ISO, and IEC standards
  • Strong oral and written communication skills

Work Rights

Not specified

Tailored Resume

Cover Letter