Medical Records Management Testing & Validation Consultant

Posted 8hrs ago

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Job Description

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

Responsibilities:

  • 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