Software Senior Quality Assurance Engineer

Salary :

Activity area : Technology

Post category : Technologies

Province : Ontario, Quebec

Region :

Recruiter : Julie Guedj

Contact us : jguedj@st-amour.com

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.