Senior Quality Engineer – QMS & Test Automation
About RxPx:
RxPx is a global digital health platform that helps doctors, patients and caregivers more easily manage complex conditions and therapies. Our No Patient Alone mission unites a passionate, smart, dedicated team of developers, designers, data scientists, health professionals and business leaders.
As a PE-backed company, with substantial success, awards and customer roster in place, you will be joining a seasoned team well-respected for its thought leadership and consultative approach to building long-term partnerships within the pharmaceutical, life sciences and healthcare ecosystem.
The Role:
We are looking to add an experienced full-time Senior Quality Engineer to join our amazing team!
This role is open to candidates in Canada.
As a Senior Quality Engineer, you will lead and scale our Quality Management System (QMS) practices while providing oversight of testing activities across multiple deployments. This role blends quality leadership and governance with hands-on involvement in test automation, ensuring both strategic oversight and practical technical contribution.
You will be responsible for maintaining compliance with regulatory standards, driving release readiness across parallel product lines, and ensuring robust traceability between requirements, risks, and verification evidence. At the same time, you will design and extend automation frameworks, keeping selected automated suites current, and support your leadership with technical credibility.
You will report to the Senior Project Lead and play a central role in ensuring our products are safe, compliant, and consistently high quality.
Objectives of the Role:
Maintain and evolve the company QMS to meet ISO 13485 / IEC 62304 / 21 CFR 820 / 21 CFR Part 11 / FDA CSA expectations, including policies, procedures, and controlled documentation.
Write, review, and manage detailed test cases, test plans, and test matrices that map to product requirements and risk controls.
Drive end-to-end traceability between requirements, risk controls, and verification activities; ensure artifacts are suitable for audits and regulatory submissions.
Define and oversee test strategies across teams, balancing automated and manual verification. Guide us the use of automation frameworks.
Perform and document manual verification and exploratory testing where automation is not suitable.
Partner with product, engineering, security, and regulatory teams to support design controls, risk management (FMEA), and release readiness reviews.
Design, implement, and maintain automated test suites for web, mobile, and APIs (end-to-end, regression, and integration), and integrate those suites into CI/CD pipelines.
Build and maintain test automation frameworks or extend existing frameworks (e.g., Cypress, Playwright / Selenium / Appium) using best-practice patterns.
Support internal and external audits; prepare and present test evidence and QMS artifacts for regulators or customers.
Identify gaps, optimize processes, and implement metrics that ensure ongoing improvement in quality outcomes.
Mentor junior QA engineers and help grow QA best practices across the company.
Qualifications
5+ years in QA / software testing, with at least 2 years combining quality oversight and test automation.
Demonstrated experience managing or contributing to QMS practices in regulated domains (SaMD, medical device software, healthcare).
Proven ability to write test cases linked to requirements and risk controls for traceability.
Hands-on automation experience with frameworks like Cypress, Playwright, Selenium, or Appium.
Familiarity with CI/CD systems (GitHub Actions, Jenkins, GitLab CI).
Strong knowledge of test management and eQMS tools (TestRail, Jira, Azure DevOps, Greenlight, MasterControl, etc.).
Excellent written communication skills suitable for audits and compliance documentation.
Preferred / Nice-to-have skills
Experience with ISO 13485, IEC 62304, 21 CFR 820 / 21 CFR Part 11 / FDA CSA compliance in a software context.
Experience with API testing tools (Postman, Newman) and contract testing.
Familiarity with cloud environments (AWS/Azure/GCP) and infrastructure-as-code testing strategies.
Prior experience at a startup or scaleup and comfort with ambiguity and rapidly evolving product scope.
What success looks like in 90 days
QMS baseline: You are familiar with and understand our existing policies, templates, and controlled documentation. You have a high-level plan for improving those and have already started implementing it to support multi-deployment verification.
Test coverage: You know which core product flows should be covered by automated test suites run in CI with reliable pass/fail signals. You tried several possibilities and have a reliable implementation plan.
Traceability: Requirements, risks, and test evidence linked for at least one major feature or release. You know how to measure success from the quality perspective.
Process: You are at the forefront of the release readiness process and have visibility into established quality metrics.
Join us!
Be an early influence on product quality and compliance at a mission-driven company.
Opportunity to shape QMS and verification strategy ahead of scale.
Competitive compensation, equity, and flexible work arrangements.