Lead Quality Program: Own the quality and validation program for the new Hub product stream and its partner integrations.
Define Test Strategy: Establish and enforce a risk-based, automation-first test strategy focusing on APIs and async workflows.
Ensure Clinical Rigor: Build clinical-grade end-to-end validation for reporting/write-back and establish release gates with complete traceability.
Maintain Compliance: Partner with engineering and regulatory teams to maintain SaMD-grade rigor, QMS compliance, and audit readiness.
Develop Test Assets: Create comprehensive test plans, complex data sets, and detailed test cases for next-generation products.
Drive Automation: Lead efforts to enhance testing efficiency through the development, maintenance, and improvement of test automation and regression tests. Architect automated reporting pipelines that generate 21 CFR Part 11 compliant evidence and traceability matrices directly from test execution.
Execute Validation: Perform end-to-end manual system validation and exploratory testing across the platform.
API and Service Testing: Test APIs and backend services to ensure compliance with technical specifications.
Manage Defects: Drive defect prioritization and perform thorough impact analysis to ensure resolution.
Advocate for Quality: Act as the Quality Bar-Raiser, participating in design and planning to embed quality early in the development lifecycle.

Requirements

10+ Years in Regulated SQA: Extensive experience in SaMD (Software as a Medical Device), including the full V&V lifecycle and authoring evidence for FDA 510(k), De Novo, or PMA submissions.
SDET-Level Engineering: High proficiency in at least one language (Python, Java, or C#) to build custom automation frameworks, API test suites, and E2E harnesses that simulate complex clinical environments (PACS/EHR).
Regulatory DevOps: Hands-on experience implementing "Traceability-as-Code," integrating automated compliance checks, and managing release gates within a CI/CD pipeline.
Standards & Interoperability: Deep knowledge of healthcare data standards (DICOM, HL7, FHIR) and medical device software standards (ISO 13485, IEC 62304).
Audit & Change Management: Expert at navigating change control, performing impact assessments, and producing audit-ready validation packages (Trace Matrices, Protocols, and Reports).
Cross-Functional Leadership: Proven ability to bridge the gap between Engineering, Clinical, and Regulatory teams to define and enforce the "Definition of Done."

Benefits

Cleerly offers a variety of medical, dental, and vision plans, designed to fit you and your family’s needs.
Our 401(k) program helps you invest in the future.
This role is eligible for a 15% target annual bonus.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

PythonJavaC#test automationAPI testingend-to-end validationregression testingtest strategyrisk-based testingdata sets

Soft Skills

cross-functional leadershipcommunicationcollaborationproblem-solvingquality advocacyimpact analysisdefect managementchange managementplanningdesign participation

Certifications

ISO 13485IEC 62304