Develop and implement standard operating procedures (SOPs) and quality management Systems (QMS) following the ISO 13485/21/CFR part 820, cGMP compliance and other regulatory standards. Develop Process Flow diagram (PFD), Process Failure Mode Effect Analysis (PFMEA) and develop Quality control plans to mitigate or eliminate risk (Risk Control/Mitigation). Execute validation activities for IQ/OQ/PQ/TQ, re-qualification, and re-validation. Lead numerous Rapid Responses and work on Non-conformance Material Reports (NCMR) including investigation, evaluation and root cause analysis with cross functional teams. Master’s degree in Science, Technology, or Engineering (any) 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.