Related skills
java python api ci/cd fhir📋 Description
- Lead quality program: Own QA for the Hub product stream and partner integrations.
- Define test strategy: risk-based, automation-first tests for APIs and async flows.
- Ensure clinical rigor: end-to-end validation with full traceability.
- Maintain compliance: SaMD-grade rigor, QMS, and audit readiness.
- Develop test assets: plans, data sets, and test cases.
- Drive automation: automate tests and reporting for compliance.
🎯 Requirements
- 10+ years in regulated SQA; SaMD lifecycle; FDA 510(k)/De Novo/PMA.
- SDET-level: Python/Java/C#; build automation frameworks; API tests; PACS/EHR.
- Regulatory DevOps: Traceability-as-Code; automated checks; CI/CD release gates.
- Standards & Interoperability: DICOM, HL7, FHIR; ISO 13485; IEC 62304.
- Audit & Change Management: Change control; impact analysis; audit-ready validation packs.
- Education: Bachelor's degree in Computer Engineering, Electrical & Electronics Engineering, or related field.
🎁 Benefits
- Equity via stock options
- Medical, dental, and vision plans
- 401(k) program
- Growth opportunities via Cleerly U
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