Software Quality Assurance Specialist

2 days ago

Melbourne, Victoria, Australia beBeeQuality Full time $80,000 - $100,000
Job Overview

This pivotal role is responsible for driving a quality-focused culture within an organisation, ensuring the delivery of compliant, high-performing software solutions.

Main Responsibilities
  • Apply specialist knowledge and regulatory expertise to ensure software development activities align with industry standards and regulations.
  • Develop and implement quality-driven approaches across the entire software development lifecycle (SDLC), from planning and design to verification, validation, and risk management.
  • Collaborate with cross-functional teams to guarantee software requirements, design, verification, and validation meet compliance criteria.
  • Participate in and approve key design input and output deliverables, such as requirements, test plans, and validation reports.
  • Lead and support risk management activities, including system-level risk analysis and software FMEAs.
Requirements
  • 3-5+ years of experience in software quality assurance within the FDA-regulated medical device industry.
  • Hands-on involvement in SaMD (Software as a Medical Device) or SiMD (Software in a Medical Device) projects.
  • In-depth knowledge of relevant standards and regulations, including 21 CFR Part 820/11, ISO 13485, IEC 62304, ISO 14971, and HIPAA.
  • Demonstrated experience with both Agile and Waterfall SDLC methodologies.
  • Strong proficiency in risk management, requirements management, verification and validation, and documentation.

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