Primary Software Quality Engineer - Ottava

Johnson & Johnson

Santa Clara, California, United States
Base: $110,000 - $130,000; bonus/equity: eligible ...
Not specified (assumed to be in-office based on location).
Computerized system validation activities
Risk-based approach for qms processes
Verification and validation of product software
Johnson & Johnson is seeking a Primary Software Quality Engineer for their Ottava team in Santa Clara, California. This full-time role focuses on supporting computerized system validation activities and ensuring compliance with quality management systems for surgical robotics software development

Job Summary

  • This role supports computerized system validation activities for Non-Product software in Surgical Robotics product development.
  • The position requires applying a risk-based approach to maintain the quality management system using audit results and data analysis.
  • Employees are eligible for comprehensive benefits including medical, dental, vision, 401(k), and extensive paid time off policies.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Primary Software Quality Engineer for their Ottava team in Santa Clara, California. This full-time role focuses on supporting computerized system validation activities and ensuring compliance with quality management systems for surgical robotics software development.

Salary

Base: $110,000 - $130,000; Bonus/Equity: Eligible for long-term incentive program; Benefits: Medical, dental, vision, 401(k), pension, and various leave policies

Skills & Requirements

Must-have

  • Computerized system validation activities
  • Risk-based approach for QMS processes
  • Verification and validation of product software
  • ISO 13485 ISO14971 IEC62304 compliance
  • 21 CFR Part 820 and 21 CFR Part 11 regulations

Nice-to-have

  • Collaboration with project program teams
  • Technical design review participation
  • CAPA and audit support experience
  • Communication of business opportunities

Key Requirements

  • Master's degree in Electrical Engineering or Computer Science
  • 6 months of experience in Primary Software Quality Engineer role
  • Knowledge of global standards and medical device regulations

Work Rights

Not specified

Tailored Resume

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