Medical Device Software Validation
Our client is a large medical device manufacturer of class II and III products. This individual will be assisting the remediation team to develop, review, analyze, and validate systems used in the manufacturing and testing of Automated External Defibrillators (AED) and related accessories.
Day to Day responsibilities will include:
Ability to assess product and system performance
Demonstrated abilities supporting system and process validation throughout product lifecycle
Project management skills with the ability to work with cross functional teams
Knowledge of tools and processes related to risk management
Experience defining and documenting validation tests, including peer review and maintaining traceability to requirements
Manage, generate and execute protocols for the Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of GMP equipment. Perform Gap Analysis and Remediation of GMP quality systems
Perform system validation for 21 CFR Part 11 compliance.
Process Validation, Software Validation, and Equipment Validations
Job Type: Contract