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Software Senior Quality Assurance EngineerSt-Amour • Montreal, QC
Software Senior Quality Assurance Engineer

Software Senior Quality Assurance Engineer

St-Amour • Montreal, QC
19 days ago
Job type
  • Permanent
Job description

Job description :

Our client is an innovative and rapidly growing company operating in the Software as a Medical Device (SaMD) space. In a dynamic startup environment, they are seeking a Senior QA Engineer to strengthen their quality culture and ensure regulatory compliance and product safety throughout the entire product lifecycle.

Your role :

Quality Assurance & Risk-Based Testing

  • Plan and execute manual software testing, including functional, exploratory, usability-focused, and risk-based testing.
  • Design, develop, and maintain automated tests (unit, integration, system, regression).
  • Apply ISO 14971 risk management principles to adapt testing depth according to product risk levels.
  • Identify automation opportunities while maintaining rigorous manual testing when necessary.

Verification, Validation & Design Controls

  • Perform verification and validation activities in compliance with IEC 62304.
  • Author and maintain DHF documentation, including test protocols, test cases, test reports, and traceability matrices.
  • Ensure full traceability between requirements, risk controls, and test evidence.
  • Actively participate in design reviews, bringing a quality and patient safety perspective.

Cross-Functional Collaboration

  • Work closely with Engineering and Product teams to improve testability and prevent defects early in the development process.
  • Provide pragmatic quality recommendations that support rapid development without compromising compliance.
  • Contribute to release readiness decisions by presenting clear quality and risk assessments.

Audit Support & Continuous Improvement

  • Maintain audit-ready documentation at all times.
  • Participate in internal audits, external audits, and regulatory inspections.
  • Contribute to root cause investigations, CAPA activities, and continuous improvement initiatives.

Skills and qualifications :

  • Minimum of 5 years of experience in Quality Assurance within a regulated software environment, ideally in SaMD.
  • Bilingual FR/EN
  • Strong hands-on experience in both manual and automated testing.
  • Practical experience with design controls, DHF documentation, and ISO 14971 risk-based testing.
  • Knowledge of regulatory requirements applicable to medical device software.
  • Ability to work independently and exercise sound quality judgment in a startup environment.
  • Strong analytical skills, attention to detail, and sense of ownership.
  • Excellent communication and collaboration skills.
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Software Senior Quality Assurance Engineer • Montreal, QC

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