Medical Records Management Testing & Validation Consultant
Posted 8hrs ago
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Job Description
Testing & Validation Consultant supporting hands-on testing of medical records management application with a focus on regulatory compliance within healthcare.
Responsibilities:
- Support hands-on testing and compliance validation of a medical records management and electronic document management application operating within a regulated healthcare environment.
- Perform functional, security, compliance, privacy, and data integrity testing of systems managing sensitive healthcare and electronic records.
- Execute compliance validation activities related to HIPAA, FDA 21 CFR Part 11, ISO 16175-1, and ISO 14641 requirements.
- Review system functionality related to electronic records management, electronic signatures, audit trails, access controls, and user permissions.
- Develop and execute test plans, test cases, validation scripts, traceability matrices, and compliance validation documentation.
- Validate data integrity, record authenticity, retention, and system security controls.
- Document findings, risks, gaps, and recommendations.
Requirements:
- Experience testing or validating medical records systems
- Experience testing or validating electronic document management systems (EDMS)
- Experience testing or validating Electronic health record (EHR/EMR) systems
- Hands-on experience with software testing and validation in regulated healthcare, pharmaceutical, biotech, medical device, laboratory, or records management environments
- Strong understanding of HIPAA Privacy Rule
- Strong understanding of HIPAA Security Rule
- Familiarity with FDA 21 CFR Part 11
- Experience validating electronic records
- Experience validating electronic signatures
- Experience validating audit trails
- Experience validating access controls
- Experience validating security safeguards
- Experience validating data integrity controls
- Ability to analyze regulatory requirements and translate them into testable validation criteria
Benefits:
- Equal Opportunity Employer

















