Location: San Diego CA
Duration: 3 month Extendable
Minimum 5 -10 years of experience in software validation of R&D, Manufacturing and large scale computer systems (e.g. HP Quality Center, SAP, Trackwise, Enovia, Windchill, DOORS, etc.)
Experience working in disciplined regulated industry in the application of automated technology particularly 21 CFRpart 820, Part 11, ISO 13485, AAMI TIR 36, FDA Guidance, General Principles of Software Validationand GAMP 5.
Experience and Understanding of current inspectional practices of FDA, notified bodies and other regulatory agencies including previous interface with such bodies during regulatory assessments or inspections.
Experience in leading and educating teams on the appropriate validation documentation created as objective evidence for software validations per company procedures, standards and regulations (e.g. 21 CFR part 820, Part 11, ISO 13485, AAMI TIR 36, FDA Guidance, General Principles of Software Validation and GAMP 5).
Applied knowledge and understanding of (IQ) Installation Qualification, (OQ) Operational Qualification, (PQ) Performance Qualification, (UAT) User Acceptance Testing, (SAT) System Acceptance Testing.
Ability to apply current inspectional techniques to project documentation during the system lifecycle and prior to FDA inspection and notified bodies to ensure a comprehensive documentation package is created and maintained.
Demonstrated ability to interact and communicate (both oral and written) with junior project team/ organizational members, business leaders and senior executives.
Effective judgment and decision making skills, typically made under stressful situations.
Competency in project management and the execution of multiple projects.
Demonstrated capability in critical thinking and leadership with strong abilities in relationship management.
Ability and willingness to travel 20% domestic and international.
Fluent in English, Spanish is a plus but not required.