Job Description:
We are seeking a seasoned software quality assurance expert to spearhead our efforts in developing and maintaining secure, high-quality software solutions for the medical device industry. This individual will be responsible for leading and supporting global software quality engineering activities, ensuring compliance with regulatory requirements and industry standards.
This role involves approximately 80% time spent on software quality engineering tasks and 20% on broader quality assurance responsibilities, including document control, corrective action planning, change management, supplier evaluation, and audit readiness.
This is a hybrid position based in our Gold Coast office, requiring occasional travel to Brisbane for collaborative work and hands-on activities.
Key Responsibilities
* Spearhead secure software development lifecycle (SDLC) and risk management processes, adhering to IEC 62304, ISO 14971, and FDA guidelines.
* Review and approve software development documentation, including threat modeling, architecture, verification protocols, configuration management, and software bills of materials.
* Collaborate with software engineers to ensure secure-by-design product development.
* Participate in vulnerability assessments, penetration testing, and third-party risk management activities.
* Maintain cybersecurity risk assessments, controls, and traceability matrices.
* Ensure design and process changes maintain a robust cybersecurity posture throughout the device lifecycle.
* Support audit and regulatory submissions related to software and cybersecurity compliance.
Required Skills & Qualifications:
* Bachelor's degree in software engineering, computer science, 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 IEC 62304, ISO 14971, and current FDA and international cybersecurity guidance.
* Familiarity with cybersecurity risk management frameworks (e.g., NIST, ISO 27001).
* Experience reviewing technical documentation for medical or safety-critical software.
* Excellent written and verbal communication skills.
Benefits:
* Generous vacation and PTO policies, with increasing time off as tenure grows.
* Comprehensive health insurance options, including dental and vision coverage.
* Short-term and long-term disability insurance.
Incentives:
* Short-term and long-term incentives are also part of our benefit package.