Primary Software Quality Engineer - Ottava

Auris Health, Inc.

Santa Clara, California, United States of America
Base: $110,000 - $130,000; bonus/equity: not speci...
Not specified
Computerized system validation
Quality management system
Risk-based approach
Auris Health, Inc. is seeking a Primary Software Quality Engineer to support computerized system validation in surgical robotics product development. The ideal candidate should have a Master's degree in a relevant field and some experience in software quality engineering, with a focus on maintaining quality management systems. The position offers competitive pay and a comprehensive benefits package

Job Summary

  • Support computerized system validation activities for various platforms' Non-Product software in Surgical Robotics product development.
  • Identify and implement necessary changes to ensure and maintain the continued suitability and effectiveness of the quality management system (QMS) using quality policy, quality objectives, audit results, and analysis of data.
  • Collaborate with project/program teams to ensure software deliverables and tasks align with applicable company procedures, global standards (ISO 13485, ISO14971, IEC62304), and regulations (21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/Medical Device Regulation (MDR)).

Matching Summary

Match Score: 75

Auris Health, Inc. is seeking a Primary Software Quality Engineer to support computerized system validation in surgical robotics product development. The ideal candidate should have a Master's degree in a relevant field and some experience in software quality engineering, with a focus on maintaining quality management systems. The position offers competitive pay and a comprehensive benefits package.

Salary

Base: $110,000 - $130,000; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • computerized system validation
  • quality management system
  • risk-based approach
  • verification and validation
  • software requirements and specifications
  • ISO 13485 and ISO14971
  • IEC62304 and 21 CFR Part 820

Nice-to-have

  • inclusive work environment
  • respect diversity and dignity
  • profoundly impact health

Key Requirements

  • Master's degree in Electrical Engineering, Computer Science or related field
  • 6 months of experience in the job offered
  • Primary Software Quality Engineer - Ottava-related occupation

Work Rights

Not specified

Tailored Resume

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