Medical Records Management Testing & Validation Consultant

TestPros, Inc.

Testing & Validation Consultant supporting hands-on testing of medical records management application with a focus on regulatory compliance within healthcare.

Posted 5/27/2026part-timeRemote • 🇺🇸 United StatesMid-LevelSeniorWebsite

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

functional testingsecurity testingcompliance testingprivacy testingdata integrity testingtest planstest casesvalidation scriptstraceability matricescompliance validation documentation

Soft Skills

analytical skillsdocumentation skills

Tools & Technologies

medical records management systemselectronic document management systemselectronic health record systems

Industry Keywords

HIPAAFDA 21 CFR Part 11ISO 16175-1ISO 14641electronic signaturesaudit trailsaccess controlsuser permissionsregulatory compliancehealthcare environment

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Equal Opportunity Employer