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

Remote

Part Time to Full Time

Experienced

Company Overview:

TestPros is a successful and growing business, established in 1988 to provide Information Technology (IT) technical support services to a wide range of Commercial and U.S. Federal, State, and Local Government customers. Our capabilities include Program Management, Program Oversight, Process Audit, Intelligence Analysis, Cyber Security, NIST 800-53, NIST SP 800-171 / CMMC Consulting/Assessment/Compliance, PCI Compliance, HIPAA, SOC 2, GLBA, Zero Trust, Resiliency, Computer Forensics, Software Supply Chain Assurance, Software Testing, Test Automation, Section 508 and WCAG Accessibility Assessment and Remediation, Localization Testing, Independent Verification and Validation (IV&V), Quality Assurance (QA), Compliance, and Research and Development (R&D) services. TestPros is an Equal Opportunity Employer.

Position: Part time (as needed, 1099 or Corp. to Corp)

Position Summary

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.

Key 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

Required Experience

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

Preferred Experience

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

Testing Areas of Focus

Functional testing
Security testing
Compliance validation
Privacy and data integrity review

Performance/load testing is not currently required.

Deliverables

Test plans and test cases
Validation protocols and scripts
Compliance assessment documentation
Defect and remediation reports
Final validation summary/report

TestPros, Inc. is an Equal Opportunity Employer.

EEO Statement

All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, marital status, age, national origin, or protected veteran status.

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Describe your experience testing:

Medical records systems
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ISO 16175-1
ISO 14641*

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