Bachelor’s degree in Engineering, Science, or a related technical discipline
Required Previous Experiences
At least 5 years of Principal or Lead Auditor experience in a regulated industry with current certifications
At least 3 years of experience in manufacturing, quality engineering, R&D, compliance, quality operations, servicing, refurbishing, chemical compliance, or clinical studies
Experience planning, leading, and supporting internal, external, corporate, site, FDA, supplier, acquisition, transfer, and risk-based audits
Experience with process, equipment, design, test method, and software validation
Experience maintaining electronic audit systems or eQMS audit functionality
Experience supporting FDA inspection readiness, including front-room and back-room activities