Medical Records Management Testing & Validation Consultant

Role Overview

• 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