Medical Records Management Testing & Validation Consultant (Part Time, Remote)

TestPros • Sterling, VA

1d • Remote

About The Position

We are seeking an experienced Testing & Validation Consultant to support hands-on testing and compliance validation of a medical records management and electronic document management application operating within a regulated healthcare and/or FDA-related environment. The consultant will perform functional, security, compliance, privacy, and data integrity testing of systems managing sensitive healthcare and electronic records. The ideal candidate will have experience validating applications against regulatory and records management standards including HIPAA, FDA 21 CFR Part 11, ISO 16175-1, and ISO 14641. This role is focused on practical testing and validation activities rather than high-level IV&V oversight only.

Requirements

• Experience testing or validating: Medical records systems, Electronic document management systems (EDMS), Electronic health record (EHR/EMR) systems, Records archive or controlled electronic records applications
• 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, HIPAA Security Rule, FDA 21 CFR Part 11
• Experience validating: Electronic records, Electronic signatures, Audit trails, Access controls, Security safeguards, Data integrity controls
• Experience developing and executing functional and compliance test cases
• Ability to analyze regulatory requirements and translate them into testable validation criteria

Nice To Haves

• Experience with ISO 16175-1:2020 functional requirements for digital records management systems
• Experience with ISO 14641:2018 electronic document preservation and traceability requirements
• Experience performing privacy reviews and compliance assessments involving PHI/ePHI
• Experience supporting FDA-regulated or GxP environments
• Familiarity with records retention, legal admissibility, and long-term digital preservation requirements
• Experience supporting validation documentation for audits or regulatory reviews

Responsibilities

• Perform hands-on functional testing of medical records management or electronic records applications
• 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 and audit logging, Access controls and user permissions, Encryption and secure transmission, Data retention and traceability, Privacy and protected health information (PHI/ePHI) handling
• Develop and execute: Test plans, Test cases, Validation scripts, Traceability matrices, Defect reports, Compliance validation documentation
• Validate data integrity, record authenticity, retention, and system security controls
• Review prior internal validation documentation and enhance or develop updated testing documentation
• Coordinate with stakeholders to identify testing scope, compliance objectives, and remediation priorities
• Document findings, risks, gaps, and recommendations

What This Job Offers

• Job Type: Part-time
• Career Level: Mid Level
• Education Level: No Education Listed