Quality Assurance Professional – Software Development Compliance

16 hours ago

Gold Coast, Queensland, Australia beBeeCybersecurity Full time $145,000 - $175,000

Job Title:

  • A quality assurance professional is required to lead and support software development compliance across our medical device software.
Responsibilities:
  • The ideal candidate will ensure secure software development lifecycle (SDLC) and risk management processes per relevant industry standards.
  • The job involves reviewing and approving software development documentation, including threat modeling, architecture, verification protocols, configuration management, and software bills of materials (SBOM).
  • Collaboration with cross-functional teams, such as software and systems engineers, is essential to ensure secure-by-design product development.
  • The quality engineer will participate in vulnerability assessment, penetration testing, and third-party risk management activities.
  • Maintaining cybersecurity risk assessments, controls, and traceability matrices are key responsibilities.
  • Ensuring that design and process changes maintain a robust cybersecurity posture throughout the device lifecycle is crucial.
  • Supporting audit and regulatory submissions related to software and cybersecurity compliance is also necessary.
Requirements:
  • Bachelor's degree in software engineering, computer science, biomedical engineering, or a related technical discipline.
  • Minimum 7 years of experience in software quality engineering, cybersecurity, or a regulated software development environment.
  • Strong working knowledge of relevant industry standards, such as IEC 62304 and ISO 14971.
  • Familiarity with cybersecurity risk management frameworks, such as NIST and ISO 27001.
  • Experience reviewing technical documentation for medical or safety-critical software is essential.
Preferred Qualifications:
  • Experience in Class III medical devices or implantable systems is highly desirable.
  • Familiarity with relevant industry standards, such as IEC 81001-5-1 and FDA Premarket Cybersecurity Guidance, is preferred.
  • Hands-on experience with software testing, threat modeling, SBOM tools, or vulnerability analysis is an asset.
  • ISO 13485 auditor experience or training is an advantage.
About Us:

We are a clinical stage medical device company developing a long-term therapy for patients with severe heart failure.

Our team is driven by a passion to advance this ground-breaking technology.

We are committed to creating an inclusive environment for all employees.

We strive to provide reasonable accommodation if needed.

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