Work on product performance specifications and design changes. Create, and update Failure Mode and Effects Analysis (DFMEA) for new implants and instruments. Implement CAPA actions to prevent nonconformance relating to the product, process, and operating standards. Develop Approaches and methodologies based on new Medical Device Regulation requirements. Perform internal audits in support of ISO standards. Skills Required: CAPA, Six Sigma, Gap Analysis, ISO 9001, ISO 13485, FMEA, DFMEA & PFMEA, DOE, IQ, OQ, PQ and Kaizen. Bachelor’s degree in Science, Technology, Engineering (any field) with 5 years of experience in job offered or related occupation is required. Work location: Iselin, NJ and various unanticipated locations throughout the U.S.Send Resume to HR Dept., Intellectt, Inc., 517 Route 1 South, Suite 1115, Iselin, NJ 08830.