Job DescriptionKey Responsibilities:Serve as the primary expert on Quality Management Systems including ISO 9001 and other relevant implement and maintain QMS policies procedures and internal and external audits; ensure audit readiness and follow-up on corrective with cross-functional teams to ensure QMS compliance across -depth knowledge of ISO 9001 and other quality with regulatory requirements (e.g. FDA ISO 13485 etc. if applicable).Provide training and mentorship on QMS principles tools and best quality data and metrics to identify trends and areas for risk management and root cause analysis for quality-related updated on industry regulations and standards; ensure timely updates to QMS in quality reviews CAPA processes and management review Regulations21CFR Part11 & Part 21 RegulationsHIPAAISO13485 RegulationsVerification TestingGood Manufacturing Practice RegulationsCSV RegulationsSoftware as a medical device (SaMD)IEC 62304 & 82304 RegulationsPenetration Testing Security