QA Lead

TheraPanacea; Paris; Sur place; EUR 75 000 - 95 000; Plein temps

Résumé du poste

TheraPanacea in Paris, France is seeking an experienced Software Tester for V&V and regulatory-compliant testing of ART-PLAN across Cloud and On-Prem deployments. You will design test plans, execute manual tests on alpha/beta/RC releases, and ensure traceability to SRS for audits.

You will mentor a junior tester, contribute to QMS improvements, and coordinate with Product Owners to meet acceptance criteria while maintaining IEC 62304 compliance across multiple environments.

Qualifications

• 5+ years in software testing with at least 2 years in a regulated software environment.
• Experience using test management tools and CI/CD pipelines.
• Familiarity with standards like IEC 62304 and ISO 13485 is a plus.

Responsabilités

• Review SRS and V&V documentation with Product Owners and Tech Lead.
• Design, write, and maintain test plans/protocols for ART-PLAN (Cloud & On-Prem).
• Execute manual functional tests on every candidate release (alpha, beta, RC).
• Collaborate to clarify acceptance criteria and reproduce edge cases.
• Report and prioritize defects with developers and QA.
• Perform full Verification Testing per IEC 62304.

Connaissances

Test management

ISTQB certification

Cloud testing (AWS)

CI/CD

Leadership

Communication

Regulated environment knowledge

Formation

Engineering Degree in CS/Software Engineering

Outils

Azure DevOps Test Plans

Xray

TestRail

Description du poste

• Review SRS (Software Requirements Specification) and related V&V documentation with Product Owners and Software Tech Lead
• Design, write, and maintain test plans and test protocols for ART-PLAN (Cloud and On-Premises versions)
• Execute manual functional tests on every candidate release (alpha, beta, RC)
• Collaborate with Product Owners to clarify acceptance criteria and reproduce edge-case scenarios
• Report, track, and prioritize defects in close collaboration with developers and QA
• Perform full Verification Testing in Phase 4 as defined by IEC 62304
• Validate behaviour on both AWS cloud tenants (eu-west-3, US, UK) and On-Premises deployments, including air-gapped environments
• Deliver the final GO / NO-GO recommendation at each release gate to authorize safe deployment
• Maintain traceability between SRS, test cases, and test execution results for certification audits
• Support regression analysis and impact assessment across releases
• Participate in release readiness reviews and post-release monitoring

For test automation & performance engineering

• Design and maintain the automated E2E test suite (Cypress/Playwright) integrated into the Azure DevOps CI/CD pipeline
• Design, implement, and operate Long Run Tests (24h / 48h / 72h stability runs) to detect memory leaks and performance degradation
• Design and operate Benchmark Tests to monitor computational and throughput trends across releases
• Design and operate Performance Tests (load, stress, capacity) for both Cloud and On-Premises deployments
• Maintain automated test infrastructure, monitor test stability, and triage flaky tests

For all testing activities

• Pilot and mentor one junior Software Tester, including reviewing their test plans and providing technical guidance
• Contribute to the continuous improvement of the QMS testing process (SOPs, templates, metrics)
• Review Software Design documents and participate in Software Design and Planning meetings
• Maintain the testing knowledge base and onboarding documentation for new team members
• Define and track testing KPIs (coverage, defect density, escape rate, MTTR, test execution time)
• Ensure test reporting is compliant with IEC 62304 verification requirements and fully auditable
• Participate in risk analysis activities (ISO 14971) and translate identified risks into adequate test coverage
• Contribute to CAPA investigations related to defects escaped to production
• Interact with Functional Team, Product Owners, and external consultants on testing scope, schedule, and deliverables
• Escalate blockers and GO / NO-GO risks directly to the Engineering Director
• Ensure regulatory compliance with IEC 62304, MDR 2017/745, and IEC 81001-5-1 (where applicable)
• Engineering Degree or equivalent (Computer Science, Software Engineering) — 5+ years of experience in software testing, including at least 2 years in a regulated software environment (medical device, aerospace, automotive, or equivalent)

Required skills

For software testing & V&V

• Experience with test management tools (Azure DevOps Test Plans, Xray, TestRail or equivalent)
• Knowledge of testing methodologies (ISTQB certification appreciated, risk-based testing, exploratory testing)
• Experience testing both Cloud (AWS) and On-Premises software deployments

For test automation & performance

• Experience with E2E automation frameworks (Cypress, Playwright, Selenium or equivalent)

For all testing activities

• Working knowledge of CI/CD pipelines (Azure DevOps, GitLab CI)
• Understanding of regulated software lifecycle (IEC 62304, ISO 13485, MDR); medical imaging and DICOM knowledge is a plus
• Leadership skills — ability to mentor a junior tester and coordinate testing activities
• Critical Thinking
• Communication skills — ability to interface with Product Owners, developers, and senior management

Reposting to

Engineering Director and/or Software Tech Lead

Process

• Interview with Engineering Director (1st filter - Verification on experience, mindset, feeling)
• Interview with Software Manage (2nd filter - Verification on technical knowledge)
• Interview with HR
• Case Study (2 h in our building - 45 min to prepare in site + 15 min break + 1h live presentation)