Senior Quality Engineer – QMS & Test Automation

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.

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.

Quality needs to be planned, assured, controlled and improved. As a Senior Quality Engineer, you will lead every stage of those processes. You will understand and find a way to improve our culture, QMS, and the way we approach Quality. You will need to think strategically, challenge our processes, and work across different teams and skill sets.

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 evidence. At the same time, you will help design and extend automation frameworks, keeping selected automated suites up to date, 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.

• 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 in 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.

• 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 (Git Hub Actions, Jenkins, Git Lab CI).
• Strong knowledge of test management and eQMS tools (Test Rail, Jira, Azure Dev Ops, Greenlight, Master Control, etc.).
• Excellent written communication skills suitable for audits and compliance documentation.

• 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…