Job description: Our client is an cutting-edge 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 Robust 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.

Robust analytical skills, attention to detail, and sense of ownership.

Excellent communication and collaboration skills.

📌 Software Senior Quality Assurance Engineer Montreal
🏢 St-Amour
📍 Montreal