Description
Quality Consulting Group is hiring a temporary, mid-level Quality Applications Specialist in Villalba, Puerto Rico. The role conducts compliant validation of quality information technology systems, coordinates with clients, programmers, developers, and operating personnel, identifies requirements for compliant computerized operations, maintains validation documentation, and reports regulatory status. The position requires a bachelor’s degree in engineering or science, at least 10 years of medical device industry experience, knowledge of FDA, ISO, and EU medical device regulations, and experience with CAPA, FCA, process validation, and quality management systems.
