Job title: Software QA Engineer
Job type: Permanent
Emp type: Full-time
Industry: Medical Device & Diagnostics
Functional Expertise: CQV / Validation Engineering IT / Digital / Data
Skills: Verification & Validation Software Test FDA Design Controls Software Verification Strategy Software Quality Design History SDLC Technical Design Artifacts Jira Confluence
Location: Singapore
Job ID: 33732

Job Description

Exciting opportunity for a Software QA Engineer with at least 3 years’ experience to join a medical device company here in Singapore, to take direct ownership of software quality, systems engineering discipline, and V&V planning. Reporting into the Engineering Lead, you will define the verification strategy, test coverage, and evidence completeness while partnering closely with a dedicated remote Software Test Engineer who executes test suites, regressions, and formal test reports.

 

Role

  • Own, structure, and maintain Software Requirements Specifications (SRS) and end-to-end traceability matrices.
  • Extract and document interface contracts, and architectural constraints.
  • Work with Product and Clinical leads to guarantee user needs and clinical intent map seamlessly into downstream engineering specifications without ambiguity.
  • Audit and sign off on test evidence completeness, ensuring test results satisfy verification acceptance criteria and pass regulatory scrutiny.
  • Own the software-quality documentation workstream, progressively taking on FDA premarket software documentation, design history files (DHF), verification summaries, and change-control records.
  • Maintain a strong dotted-line working relationship with the Quality & Regulatory function to align software artifacts with international standards
  • Support release-quality readiness reviews, defect triage meetings, configuration baselines, and release sign-offs.
  • Evaluate and document controlled software change records, assessing regression impact before production deployment.
  • Progressively take on cybersecurity documentation inputs, vulnerability assessments, threat modelling documentation, and patch management processes.

 

Requirements

  • Bachelor’s or Master’s degree in Computer Science, Software Engineering, Biomedical Engineering, or a related discipline (or equivalent practical experience).
  • More than 3 years of experience in software quality assurance, systems engineering, or software engineering with a primary focus on requirements management and V&V.
  • Demonstrated track record managing structured Software Requirements Specifications (SRS) and end-to-end requirement traceability.
  • Solid understanding of the complete Software Development Life Cycle (SDLC) across multi-tier environments (mobile, cloud, web, and APIs).
  • Hands-on ability to read and critique technical design artifacts, API interfaces, and user stories to extract detailed verification criteria.
  • Experience structuring test plans, acceptance criteria, and verification matrices mapped to system requirements.
  • Strong technical writing and communication skills; able to bridge clinical/product expectations, software architecture, and regulatory compliance.
  • Experience in Jira, Confluence or similar
  • Experience with automated testing tools, CI/CD pipelines, or connected IoT/BLE device ecosystems advantageous

 

Interested candidates, please submit your profile to submitCV@talentreq.com for review. We will be in touch for initial discussion upon being shortlisted.

EA Licence: 17S8795 | EAP: R1108333