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.

TestPros

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