[YOUR NAME] [City, State] | [Phone Number] | [Email Address] LinkedIn: [Profile URL] PROFESSIONAL SUMMARY Healthcare QA analyst with 5+ years of experience testing medical software and electronic health record systems. Expert in FDA regulations, HIPAA compliance, and healthcare industry standards. Proven track record of ensuring patient safety through rigorous testing of clinical applications. Strong understanding of healthcare workflows and regulatory requirements. TECHNICAL SKILLS Healthcare Standards: HIPAA, FDA 21 CFR Part 11, IEC 62304, ISO 13485, HL7, FHIR Testing Tools: JIRA, TestRail, HP ALM, Selenium WebDriver, Postman Testing Types: Functional, Regression, Integration, Validation Testing, Security Testing, Compliance Testing Technologies: SQL, Python (Basic), Java (Basic), XML, JSON Healthcare Systems: Epic, Cerner, HL7 Integration, Electronic Health Records (EHR), Medical Imaging (DICOM) Methodologies: Agile, Waterfall, V-Model, Risk-based Testing PROFESSIONAL EXPERIENCE Healthcare QA Analyst | [Current Company Name], [City, State] | [Month Year - Present] - Lead quality assurance for EHR system used by 200+ healthcare providers serving 500K+ patients - Ensure HIPAA compliance through comprehensive security and privacy testing of patient data handling - Validate HL7 message integration between hospital systems, ensuring accurate data transmission for 50+ interfaces - Design and execute validation testing protocols compliant with FDA 21 CFR Part 11 requirements - Conduct risk-based testing focusing on patient safety and critical clinical workflows - Identified 180+ defects including 25 critical issues that could impact patient care or data security - Collaborate with clinical subject matter experts to understand medical workflows and requirements - Create and maintain validation documentation including test protocols, test scripts, and validation reports Senior QA Analyst | [Previous Company Name], [City, State] | [Month Year - Month Year] - Performed comprehensive testing for medical device software requiring FDA 510(k) clearance - Executed IVV (Independent Verification and Validation) activities per IEC 62304 standards - Conducted traceability analysis ensuring all requirements mapped to test cases and defects - Validated electronic signature functionality ensuring 21 CFR Part 11 compliance - Performed security testing focusing on PHI (Protected Health Information) protection - Coordinated with regulatory affairs team for FDA submission documentation - Reduced compliance audit findings by 70% through rigorous testing and documentation practices - Tested clinical decision support systems ensuring accurate drug interaction alerts and dosage calculations QA Analyst | [Earlier Company Name], [City, State] | [Month Year - Month Year] - Tested medical billing and claims processing software handling $50M+ in annual claims - Validated insurance eligibility verification and authorization workflows - Performed ICD-10 and CPT code validation testing ensuring accurate coding and billing - Conducted integration testing with clearinghouses and insurance payer systems - Executed HIPAA compliance testing for patient data security and privacy requirements - Created test data representing various clinical scenarios and edge cases - Participated in audit preparation and regulatory inspection support EDUCATION [Degree Name] in [Major] [University Name], [City, State] Graduated: [Month Year] CERTIFICATIONS ISTQB Certified Tester Foundation Level (CTFL) - [Year] Certified Healthcare Technology Specialist (CHTS) - [Year] HIPAA Compliance Certification - [Year] ADDITIONAL INFORMATION - Strong understanding of clinical workflows and medical terminology - Experience with FDA regulatory submissions and validation processes - Knowledge of healthcare interoperability standards (HL7, FHIR, DICOM)