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Niche SaMD and compliance requirements with seniority reduce applicant competition despite metro location.
Strong healthcare compliance and SaMD focus limits cross-industry transferability.
Explicit 15+ years, SaMD V&V, extensive regulatory and technical mandates enforce strict filters.
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Own design, development, and deployment of automated API test frameworks for data products and platforms, including AI/ML testing to ensure quality and compliance.
Lead data quality management, governance, and regulatory compliance activities across data and AI products, enforcing standards like HIPAA, GDPR, SaMD, and FDA cybersecurity.
Manage and mentor a multi-location team of test engineers and collaborate with product, architecture, and privacy teams to align testing with business and compliance requirements.
Bachelor’s degree in Computer Science or related technical field.
15+ years in Software Quality Engineering, Compliance & Test Automation, with 3+ years handling Verification & Validation for Software as a Medical Device (SaMD).
8+ years in database and cloud-based data engineering technologies (e.g., MySQL, PostgreSQL, Redshift, Kafka, AWS, Azure).
Deep expertise in compliance and regulatory requirements for medical devices including HIPAA, GDPR, FDA cybersecurity, and healthcare data interoperability standards (HL7, FHIR).
Experienced senior leader skilled in leading quality initiatives for large-scale, cloud-based data platforms in regulated healthcare environments.
Strategic thinker capable of driving test automation strategy, continuous testing, and compliance governance within agile development.
Strong operator in cross-functional collaboration managing onsite and offshore teams, vendors, and delivering measurable QA and compliance improvements in digital health solutions.