Senior Software Quality Engineer

Outset Medical

Tijuana, Mexico
On-site
5 years quality engineering experience
Medical device field experience
Iso 13485 iso 14971 iso 62304 knowledge
Outset Medical is seeking a Senior Software Quality Engineer to contribute to the development and assurance of their innovative dialysis technology. The role requires expertise in quality engineering, particularly within the medical device sector, and offers a collaborative and dynamic work environment focused on continuous improvement

Job Summary

  • The Senior Software Quality Engineer supports the Software R&D, Test, and Manufacturing departments throughout the entire product lifecycle.
  • This role requires thorough knowledge of FDA regulations, ISO standards, and IEC 62304 to ensure compliance with medical device safety requirements.
  • Outset Medical is revolutionizing dialysis care by creating technology that reduces cost and complexity while improving patient outcomes.

Matching Summary

Match Score: 85

Outset Medical is seeking a Senior Software Quality Engineer to contribute to the development and assurance of their innovative dialysis technology. The role requires expertise in quality engineering, particularly within the medical device sector, and offers a collaborative and dynamic work environment focused on continuous improvement.

Skills & Requirements

Must-have

  • 5 years Quality Engineering experience
  • Medical device field experience
  • ISO 13485 ISO 14971 ISO 62304 knowledge
  • FDA Quality System Regulations expertise
  • Software development lifecycle support

Nice-to-have

  • Certified Quality Engineer certification
  • Lead Auditor certification preferred
  • Lean Certification a plus
  • Statistical analysis software experience
  • Mentoring team members skills

Key Requirements

  • Bachelor's degree in Computer or Engineering Science
  • Minimum 5 years hands-on Quality Engineering experience
  • Prior experience in medical device field required
  • Fluent English communication skills required

Work Rights

Not specified

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